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CompletedNCT01928927TRAFICUpdated Aug 3, 2021Results posted

Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)

A Phase 2 interventional study of Telmisartan in HIV-1 Infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main goal of this study was to see if a drug called telmisartan would decrease fibrosis (scarring) and inflammation (irritation) in people who are infected with HIV and doing well on their HIV medications. The study was also done to see what effects telmisartan has on other signs of disease and inflammation in the body, and to see whether people who have HIV can take telmisartan safely and without side effects that make them want to stop the drug. Telmisartan is FDA-approved for treating high blood pressure and decreasing the chance of heart attacks and strokes in people over the age of 55 years of age who are at high risk for these events.

Read the detailed description

This was a multicenter, randomized, open label, phase IIb, two-arm study to evaluate the effects of telmisartan on fibrotic and inflammatory contributors to end-organ disease in HIV-infected subjects well controlled on antiretroviral therapy (ART). Participants were randomized 2:1 to the telmisartan and control arms. The participants on telmisartan took 40 mg telmisartan daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. The participants in the control arm did not take any study medication, but did undergo all evaluations. All participants were followed for 48 weeks after randomization.

The study clinic visits included Step 1 entry, Step 2 entry, and weeks 4, 12, 24, 36, 48. Biopsies for the primary outcomes were collected at Step 1 entry and Week 48. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, laboratory tests) were done at Step 2 entry and weeks 4, 12, 24, 36, 48.

The co-primary objectives assessed the effects of telmisartan for 48weeks on lymph node and adipose tissue collagen I deposition.

Currently, the results are entered for the primary outcome measures only. The results on the secondary outcomes will be posted when they become available.

02

Conditions studied

  • HIV-1 Infection
03

In context

Lead sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections is the lead sponsor of 70 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Step 1 Inclusion Criteria:

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to Step 1 entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV-1 RNA viral load >2000 copies/mL on two occasions.
  • On antiretroviral therapy (ART) continuously for ≥48 weeks prior to Step 1 entry.
  • Documentation of HIV-1 RNA \<50 copies/mL at screening, performed by any US laboratory that has a CLIA certification or its equivalent.
  • At least one HIV-1 RNA level \<200 copies/mL in the 48 weeks prior to Step 1 entry (not including the screening).
  • No change in ART regimen in the 12 weeks prior to Step 1 entry (except as noted below).

NOTE: Modifications of ART dosing during the 12 weeks prior to Step 1 entry are permitted. In addition, the change in formulation (eg, from standard formulation to fixed dose combination or single tablet regimen) is allowed within 12 weeks of Step 1 entry. A within-class single drug substitution (eg, switch from nevirapine to efavirenz or from atazanavir to darunavir) is allowed within 12 weeks of Step 1 entry, with the exception of a switch from any other NRTI to abacavir. No other changes in ART in the 12 weeks prior to Step 1 entry are permitted.

  • No active plan to change ART for the 48-week study duration.
  • Body mass index (BMI) 20-35 kg/m\^2.
  • For females of reproductive potential, negative serum or urine pregnancy test within 3 days prior to Step 1 entry.
  • Ability and willingness of subject or legal guardian/representative to provide informed consent.
  • Willingness to undergo the Step 1 entry and week 48 lymphoid and adipose tissue biopsies.

Step 2 Inclusion Criteria:

  • Entry lymphoid tissue and adipose tissue specimen for assay of the primary endpoint has been obtained. (Prior to Letter of Amendment #2, 11/19/14)
  • (Letter of Amendment #2, 11/19/14) Entry lymphoid tissue and adipose tissue specimens for assay of the primary endpoint have been obtained, entered into the ACTG's Laboratory Data Management System (LDMS), and confirmed by the protocol team as adequate for endpoint determination.

NOTE: If the lymph node specimen is determined by the protocol team to be inadequate for endpoint determination despite the interventions summarized in LOA #2, the participant will be permitted to enroll if adequate adipose tissue is obtained. However, as change in lymph node fibrosis remains one of the primary endpoints of this study, it is critical that every effort be made to obtain an adequate sample while still trying to minimize complication rates.

  • Willingness to undergo the week 48 lymphoid and adipose tissue biopsies. (Prior to Letter of Amendment #2, 11/19/14)
  • (Letter of Amendment #2, 11/19/14) Willingness to undergo the week 48 lymphoid and adipose tissue biopsies.

NOTE: A week 48 lymph node biopsy is not required if the Step 1 lymph node specimen was deemed inadequate as noted in 4.3.1. Week 48 adipose tissue biopsies will still be required for these participants.

Step 1 Exclusion Criteria:

  • More than one HIV-1 RNA >200 copies/mL in the 48 weeks prior to Step 1 entry.
  • One HIV-1 RNA 200-500 copies/mL in the 24 weeks prior to Step 1 entry that is not immediately preceded and followed by HIV-1 RNA \<50 copies/mL.

NOTE: The preceding viral load \<50 copies/mL may be >24 weeks prior to Step 1 entry.

  • Confirmed systolic blood pressure >160 mmHg or \<100 mmHg or diastolic blood pressure >100 mmHg.
  • Known untreated renal artery stenosis.
  • Known cirrhosis or severe liver disease (eg, ascites, encephalopathy, history of variceal bleeding).

NOTE: Potential subjects with chronic hepatitis B or C virus infection with no known cirrhosis or severe liver disease may participate in the study, provided there are no plans to start therapy for hepatitis C infection during the 48-week study duration.

  • Unstable coronary artery disease/angina or decompensated congestive heart failure.
  • Either breastfeeding or pregnant within 24 weeks prior to Step 1 entry.
  • Use of thiazolidinediones or any angiotensin receptor blocker (ARB) or angiotensin converting enzyme inhibitor (ACEi) in the 24 weeks prior to Step 1 entry. If the subject took either of these classes of medications for less than 2 weeks in the 24 weeks prior to Step 1 entry, the subject may enroll if 30 days have passed since the last dose. If the subject is diabetic and/or has a calculated glomerular filtration rate (GFR) \<60mL/min, aliskiren-containing medications are also prohibited.
  • History of intolerance, other than cough, to any ARB or ACEi.
  • Use of anticoagulants other than aspirin 81 mg or 325 mg daily. NOTE: If the subject is on aspirin 81 mg or 325 mg daily and is willing/able to stop therapy for 7 days prior to the biopsy procedures, the subject may enroll.
  • Any known bleeding disorder or coagulopathy.
  • Projected need for daily potassium supplementation for ≥2 weeks during the study period.

  • The following laboratory values obtained within 30 days prior to Step 1 entry by any US laboratory that has a CLIA certification or its equivalent:

    • Absolute neutrophil count (ANC) ≤750 cells/mm\^3
    • Hemoglobin ≤10 g/dL
    • Platelet count ≤75,000/mm\^3
    • Calculated creatinine clearance (CrCl) \<50 mL/min, as estimated by the Cockcroft-Gault equation
    • Aspartate aminotransferase (AST) (SGOT) >/=3x ULN (upper limit of normal)
    • Alanine aminotransferase (ALT) (SGPT) >/=3x ULN
    • Partial thromboplastin time (PTT) >1.2x ULN
    • Prothrombin time (PT) >1.2x ULN
  • Heritable connective tissue disorders (eg Ehlers-Danlos syndrome, osteogenesis imperfecta, Stickler syndrome, Marfan's syndrome).

NOTE: Subjects with acquired/autoimmune chronic inflammatory diseases/connective tissue disorders who are clinically stable (in the opinion of the site investigator) and not on a prohibited medication may enroll with approval of the A5317 study chairs.

  • Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to Step 1 entry.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.

Step 2 Exclusion Criteria:

  • Any AE associated with the Step 1 entry biopsy that would exclude the subject from undergoing follow-up biopsy at week 48.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Arm A: Telmisartan

    Drug: Telmisartan

  • No intervention
    Arm B: No Study Drug

    Participants received no study drug and followed the week 0-48 evaluation schedule.

Interventions

  • DrugTelmisartan

    Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

06

What researchers measure

Primary outcomes

  1. Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48

    Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.

    Time frame: baseline and week 48

  2. Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

    Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.

    Time frame: baseline and week 48

Secondary outcomes

  1. Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  2. Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  3. Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  4. Highest Grade Non-biopsy-related Adverse Event

    Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant. Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table. NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol.

    Time frame: after baseline to week 48

  5. Change in IL-6 From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  6. Change in IL-6 From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  7. Change in IL-6 From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  8. Change in IL-7 From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  9. Change in IL-7 From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  10. Change in IL-7 From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  11. Change in Adiponectin From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  12. Change in Adiponectin From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  13. Change in Adiponectin From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  14. Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  15. Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  16. Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  17. Change in Hyaluronic Acid From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  18. Change in Hyaluronic Acid From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  19. Change in Hyaluronic Acid From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  20. Change in sCD14 From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  21. Change in sCD14 From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  22. Change in sCD14 From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  23. Change in sCD163 From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  24. Change in sCD163 From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  25. Change in sCD163 From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  26. Change in TGF-β1 From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  27. Change in TGF-β1 From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  28. Change in TGF-β1 From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  29. Change in TGF-β2 From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  30. Change in TGF-β2 From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  31. Change in TGF-β2 From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  32. Change in TGF-β3 From Baseline to Week 4

    Absolute change was calculated as the value at week 4 minus the value at baseline.

    Time frame: baseline and week 4

  33. Change in TGF-β3 From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  34. Change in TGF-β3 From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  35. Change in Circulating CD4+ T Cell Count From Baseline to Week 12

    Absolute change was calculated as the value at week 12 minus the value at baseline.

    Time frame: baseline and week 12

  36. Change in Circulating CD4+ T Cell Count From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  37. Change in Circulating CD4+ T Cell Count From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  38. Change in Circulating CD8+ T Cell Count From Baseline to Week 12

    Absolute change was calculated as the value at week 12 minus the value at baseline.

    Time frame: baseline and week 12

  39. Change in Circulating CD8+ T Cell Count From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  40. Change in Circulating CD8+ T Cell Count From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  41. Change in Fasting Glucose From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  42. Change in Fasting HDL Cholesterol From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  43. Change in Fasting Insulin From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  44. Change in Fasting LDL Cholesterol From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  45. Change in Fasting Total Cholesterol From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  46. Change in Fasting Triglycerides From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  47. Change in HOMA-IR From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  48. Prevalence of Metabolic Syndrome at Week 24.

    Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III \[NCEP ATP III\] criteria) as the presence of any 3 of the following: Waist: \>40" (101.6 cm) in men, \>35" (88.9 cm) in women with the exception of Asian-Americans: \>35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C \<40 mg/dL in men, \<50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL. NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis.

    Time frame: Week 24

  49. Presence of Metabolic Syndrome at Week 48.

    Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III \[NCEP ATP III\] criteria) as the presence of any 3 of the following: Waist: \>40" (101.6 cm) in men, \>35" (88.9 cm) in women with the exception of Asian-Americans: \>35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C \<40 mg/dL in men, \<50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.

    Time frame: Week 48

  50. Change in Waist Circumference From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  51. Change in Waist Circumference From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  52. Change in Waist-to-hip Ratio From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: baseline and week 24

  53. Change in Waist-to-hip Ratio From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: baseline and week 48

  54. Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: 24 weeks

  55. Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24

    Absolute change was calculated as the value at week 24 minus the value at baseline.

    Time frame: 24 weeks

  56. Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  57. Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  58. Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  59. Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  60. Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  61. Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  62. Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  63. Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

  64. Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.

    Absolute change was calculated as the value at week 48 minus the value at baseline.

    Time frame: 48 weeks

07

Results

Posted Apr 12, 2017

Participant flow

58 participants enrolled to Step 1 between January 6, 2014 and April 13, 2015. Step 1 was a run-in period to ensure successful pre-randomization biopsies were obtained. 44 participants did have successful Step 1 biopsy and were randomized to Step 2 between January 13, 2014 and April 22, 2015.

Participant flow — Overall Study
MilestoneArm A: TelmisartanArm B: No Study Drug
Started2915
Completed2714
Not completed21
Withdrew: Lost to follow-up10
Withdrew: Withdrawal by subject11

Outcome measures

PrimaryChange in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48

Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.

Time frame:
baseline and week 48
Reported as:
Median · percent area stain positive
Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48
percent area stain positiveArm A: TelmisartanArm B: No Study Drug
Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48-2.44 (-10.60 to 3.77)-6.08 (-11.66 to 5.84)
Statistical analysis
  • Arm A: Telmisartan vs Arm B: No Study Drug · Theta statistic; DeLong & Clarke-Pearson · p = 0.97 (No adjustment for multiple comparisons) · Theta statistic: 0.50 · 95% CI 0.26 to 0.73The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.
PrimaryChange in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.

Time frame:
baseline and week 48
Reported as:
Median · percent area stain positive
Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
percent area stain positiveArm A: TelmisartanArm B: No Study Drug
Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48-1.43 (-10.61 to 4.17)0.36 (-6.57 to 6.41)
Statistical analysis
  • Arm A: Telmisartan vs Arm B: No Study Drug · Theta statistic; DeLong & Clarke-Pearson · p = 0.61 (No adjustment for multiple comparisons) · Theta statistic: 0.57 · 95% CI 0.31 to 0.83The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.
SecondaryChange in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · percent area stain positive
Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48
percent area stain positiveArm A: TelmisartanArm B: No Study Drug
Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 480.01 (-0.40 to 0.35)0.61 (-0.09 to 1.40)
SecondaryChange in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · percent area stain positive
Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
percent area stain positiveArm A: TelmisartanArm B: No Study Drug
Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48-0.82 (-4.00 to 0.45)-4.01 (-6.02 to -1.63)
SecondaryChange in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · percent area stain positive
Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
percent area stain positiveArm A: TelmisartanArm B: No Study Drug
Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48-0.41 (-4.03 to 0.31)-1.36 (-2.04 to -0.67)
SecondaryHighest Grade Non-biopsy-related Adverse Event

Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant. Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table. NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol.

Time frame:
after baseline to week 48
Reported as:
Count of participants · Participants
Highest Grade Non-biopsy-related Adverse Event
ParticipantsArm A: TelmisartanArm B: No Study Drug
Grade 0126
Grade 100
Grade 2113
Grade 355
Grade 411
SecondaryChange in IL-6 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · pg/ml
Change in IL-6 From Baseline to Week 4
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in IL-6 From Baseline to Week 4-0.50 (-0.80 to 0.11)-0.01 (-0.29 to 0.27)
SecondaryChange in IL-6 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · pg/ml
Change in IL-6 From Baseline to Week 24
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in IL-6 From Baseline to Week 24-0.53 (-0.69 to 0.04)0.04 (-0.48 to 0.85)
SecondaryChange in IL-6 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · pg/ml
Change in IL-6 From Baseline to Week 48
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in IL-6 From Baseline to Week 48-0.46 (-0.86 to 0.13)-0.03 (-0.48 to 1.18)
SecondaryChange in IL-7 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · pg/ml
Change in IL-7 From Baseline to Week 4
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in IL-7 From Baseline to Week 40.48 (-0.21 to 2.18)-0.32 (-4.34 to 0.37)
SecondaryChange in IL-7 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · pg/ml
Change in IL-7 From Baseline to Week 24
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in IL-7 From Baseline to Week 240.51 (-0.13 to 2.32)-1.36 (-3.94 to 0.44)
SecondaryChange in IL-7 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · pg/ml
Change in IL-7 From Baseline to Week 48
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in IL-7 From Baseline to Week 480.06 (-0.82 to 1.73)0.53 (-1.18 to 2.28)
SecondaryChange in Adiponectin From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · ng/ml
Change in Adiponectin From Baseline to Week 4
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Adiponectin From Baseline to Week 4177.20 (-1624.50 to 1949.70)161.00 (-528.30 to 1597.35)
SecondaryChange in Adiponectin From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · ng/ml
Change in Adiponectin From Baseline to Week 24
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Adiponectin From Baseline to Week 24-582 (-1709.30 to 714.20)1222.60 (-867.60 to 3278.15)
SecondaryChange in Adiponectin From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · ng/ml
Change in Adiponectin From Baseline to Week 48
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Adiponectin From Baseline to Week 48-138.70 (-1935.20 to 1521.70)113.80 (-3150.00 to 907.80)
SecondaryChange in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · ng/ml
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4-2.14 (-14.94 to 8.45)-9.10 (-27.38 to 14.29)
SecondaryChange in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · ng/ml
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24-13.78 (-37.69 to 5.93)-1.17 (-24.43 to 40.16)
SecondaryChange in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · ng/ml
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48-10.76 (-40.50 to 27.78)-6.10 (-31.99 to 6.36)
SecondaryChange in Hyaluronic Acid From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · ng/ml
Change in Hyaluronic Acid From Baseline to Week 4
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Hyaluronic Acid From Baseline to Week 4-0.03 (-8.46 to 16.63)3.14 (-7.29 to 14.42)
SecondaryChange in Hyaluronic Acid From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · ng/ml
Change in Hyaluronic Acid From Baseline to Week 24
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Hyaluronic Acid From Baseline to Week 24-1.62 (-18.32 to 1.19)3.71 (-5.83 to 30.20)
SecondaryChange in Hyaluronic Acid From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · ng/ml
Change in Hyaluronic Acid From Baseline to Week 48
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in Hyaluronic Acid From Baseline to Week 48-2.74 (-18.52 to 9.84)-1.79 (-6.96 to 14.49)
SecondaryChange in sCD14 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · mcg/ml
Change in sCD14 From Baseline to Week 4
mcg/mlArm A: TelmisartanArm B: No Study Drug
Change in sCD14 From Baseline to Week 4-0.03 (-0.37 to 0.08)0.05 (-0.06 to 0.25)
SecondaryChange in sCD14 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · mcg/ml
Change in sCD14 From Baseline to Week 24
mcg/mlArm A: TelmisartanArm B: No Study Drug
Change in sCD14 From Baseline to Week 240.06 (-0.19 to 0.26)-0.08 (-0.15 to 0.09)
SecondaryChange in sCD14 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · mcg/ml
Change in sCD14 From Baseline to Week 48
mcg/mlArm A: TelmisartanArm B: No Study Drug
Change in sCD14 From Baseline to Week 48-0.08 (-0.26 to 0.12)0 (-0.17 to 0.36)
SecondaryChange in sCD163 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · ng/ml
Change in sCD163 From Baseline to Week 4
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in sCD163 From Baseline to Week 434.08 (-33.96 to 174.04)0.88 (-45.16 to 106.08)
SecondaryChange in sCD163 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · ng/ml
Change in sCD163 From Baseline to Week 24
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in sCD163 From Baseline to Week 2458.72 (-44.52 to 206.52)9.58 (-49.40 to 56.72)
SecondaryChange in sCD163 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · ng/ml
Change in sCD163 From Baseline to Week 48
ng/mlArm A: TelmisartanArm B: No Study Drug
Change in sCD163 From Baseline to Week 4831.14 (-200.04 to 160.20)5.32 (-117.80 to 96.84)
SecondaryChange in TGF-β1 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · pg/ml
Change in TGF-β1 From Baseline to Week 4
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β1 From Baseline to Week 4793.37 (-2080.11 to 3877.98)-1074.87 (-5328.36 to 603.32)
SecondaryChange in TGF-β1 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · pg/ml
Change in TGF-β1 From Baseline to Week 24
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β1 From Baseline to Week 24175.02 (-1249.67 to 4478.09)678.43 (-3983.91 to 2816.12)
SecondaryChange in TGF-β1 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · pg/ml
Change in TGF-β1 From Baseline to Week 48
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β1 From Baseline to Week 48-319.17 (-3429.94 to 1203.98)-516.45 (-2307.66 to 2090.85)
SecondaryChange in TGF-β2 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · pg/ml
Change in TGF-β2 From Baseline to Week 4
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β2 From Baseline to Week 470.74 (-135.73 to 147.97)-129.40 (-272.80 to -5.13)
SecondaryChange in TGF-β2 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · pg/ml
Change in TGF-β2 From Baseline to Week 24
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β2 From Baseline to Week 2475.84 (-39.61 to 134.71)-134.68 (-345.89 to -8.64)
SecondaryChange in TGF-β2 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · pg/ml
Change in TGF-β2 From Baseline to Week 48
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β2 From Baseline to Week 4844.45 (-201.77 to 164.44)-55.94 (-201.52 to 119.60)
SecondaryChange in TGF-β3 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Time frame:
baseline and week 4
Reported as:
Median · pg/ml
Change in TGF-β3 From Baseline to Week 4
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β3 From Baseline to Week 431.26 (-39.82 to 254.89)-95.17 (-450.42 to -10.83)
SecondaryChange in TGF-β3 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · pg/ml
Change in TGF-β3 From Baseline to Week 24
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β3 From Baseline to Week 2434.64 (-16.14 to 226.95)-68.01 (-341.55 to 101.57)
SecondaryChange in TGF-β3 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · pg/ml
Change in TGF-β3 From Baseline to Week 48
pg/mlArm A: TelmisartanArm B: No Study Drug
Change in TGF-β3 From Baseline to Week 48-0.47 (-176.53 to 175.68)-55.21 (-163.05 to 135.04)
SecondaryChange in Circulating CD4+ T Cell Count From Baseline to Week 12

Absolute change was calculated as the value at week 12 minus the value at baseline.

Time frame:
baseline and week 12
Reported as:
Median · cells/mm^3
Change in Circulating CD4+ T Cell Count From Baseline to Week 12
cells/mm^3Arm A: TelmisartanArm B: No Study Drug
Change in Circulating CD4+ T Cell Count From Baseline to Week 12-17.50 (-133 to 26)59.50 (-24 to 108)
SecondaryChange in Circulating CD4+ T Cell Count From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · cells/mm^3
Change in Circulating CD4+ T Cell Count From Baseline to Week 24
cells/mm^3Arm A: TelmisartanArm B: No Study Drug
Change in Circulating CD4+ T Cell Count From Baseline to Week 2413 (-55 to 95)61.5 (-16.5 to 186.5)
SecondaryChange in Circulating CD4+ T Cell Count From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · cells/mm^3
Change in Circulating CD4+ T Cell Count From Baseline to Week 48
cells/mm^3Arm A: TelmisartanArm B: No Study Drug
Change in Circulating CD4+ T Cell Count From Baseline to Week 489 (-24 to 45)97 (4 to 111)
SecondaryChange in Circulating CD8+ T Cell Count From Baseline to Week 12

Absolute change was calculated as the value at week 12 minus the value at baseline.

Time frame:
baseline and week 12
Reported as:
Median · cells/mm^3
Change in Circulating CD8+ T Cell Count From Baseline to Week 12
cells/mm^3Arm A: TelmisartanArm B: No Study Drug
Change in Circulating CD8+ T Cell Count From Baseline to Week 12-33.5 (-130 to 111.5)83 (30 to 154)
SecondaryChange in Circulating CD8+ T Cell Count From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · cells/mm^3
Change in Circulating CD8+ T Cell Count From Baseline to Week 24
cells/mm^3Arm A: TelmisartanArm B: No Study Drug
Change in Circulating CD8+ T Cell Count From Baseline to Week 24-3.5 (-97 to 103.5)80.5 (-8 to 181.5)
SecondaryChange in Circulating CD8+ T Cell Count From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · cells/mm^3
Change in Circulating CD8+ T Cell Count From Baseline to Week 48
cells/mm^3Arm A: TelmisartanArm B: No Study Drug
Change in Circulating CD8+ T Cell Count From Baseline to Week 4810 (-72 to 101)97 (-24 to 169)
SecondaryChange in Fasting Glucose From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · mg/dl
Change in Fasting Glucose From Baseline to Week 48
mg/dlArm A: TelmisartanArm B: No Study Drug
Change in Fasting Glucose From Baseline to Week 484 (-3 to 8)2 (-5 to 12)
SecondaryChange in Fasting HDL Cholesterol From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · mg/dl
Change in Fasting HDL Cholesterol From Baseline to Week 48
mg/dlArm A: TelmisartanArm B: No Study Drug
Change in Fasting HDL Cholesterol From Baseline to Week 48-1 (-6 to 1)-4 (-7 to 6)
SecondaryChange in Fasting Insulin From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · uIU/ml
Change in Fasting Insulin From Baseline to Week 48
uIU/mlArm A: TelmisartanArm B: No Study Drug
Change in Fasting Insulin From Baseline to Week 483 (-1 to 4)0 (-2 to 8)
SecondaryChange in Fasting LDL Cholesterol From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · mg/dl
Change in Fasting LDL Cholesterol From Baseline to Week 48
mg/dlArm A: TelmisartanArm B: No Study Drug
Change in Fasting LDL Cholesterol From Baseline to Week 48-12 (-30.2 to 12)-7.4 (-20.6 to 18.8)
SecondaryChange in Fasting Total Cholesterol From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · mg/dl
Change in Fasting Total Cholesterol From Baseline to Week 48
mg/dlArm A: TelmisartanArm B: No Study Drug
Change in Fasting Total Cholesterol From Baseline to Week 48-8 (-23 to 4)-2 (-8 to 9)
SecondaryChange in Fasting Triglycerides From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · mg/dl
Change in Fasting Triglycerides From Baseline to Week 48
mg/dlArm A: TelmisartanArm B: No Study Drug
Change in Fasting Triglycerides From Baseline to Week 487 (-23 to 29)-16 (-23 to 63)
SecondaryChange in HOMA-IR From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · (mg/dl)x(uIU/ml)/405
Change in HOMA-IR From Baseline to Week 48
(mg/dl)x(uIU/ml)/405Arm A: TelmisartanArm B: No Study Drug
Change in HOMA-IR From Baseline to Week 480.76 (-0.02 to 1.01)-0.04 (-0.42 to 1.03)
SecondaryPrevalence of Metabolic Syndrome at Week 24.

Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III \[NCEP ATP III\] criteria) as the presence of any 3 of the following: Waist: \>40" (101.6 cm) in men, \>35" (88.9 cm) in women with the exception of Asian-Americans: \>35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C \<40 mg/dL in men, \<50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL. NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis.

Time frame:
Week 24
Reported as:
Count of participants · Participants
Prevalence of Metabolic Syndrome at Week 24.
ParticipantsArm A: TelmisartanArm B: No Study Drug
Metabolic syndrome61
No metabolic syndrome1510
SecondaryPresence of Metabolic Syndrome at Week 48.

Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III \[NCEP ATP III\] criteria) as the presence of any 3 of the following: Waist: \>40" (101.6 cm) in men, \>35" (88.9 cm) in women with the exception of Asian-Americans: \>35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C \<40 mg/dL in men, \<50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.

Time frame:
Week 48
Reported as:
Count of participants · Participants
Presence of Metabolic Syndrome at Week 48.
ParticipantsArm A: TelmisartanArm B: No Study Drug
Metabolic syndrome70
No metabolic syndrome1413
SecondaryChange in Waist Circumference From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · cm
Change in Waist Circumference From Baseline to Week 24
cmArm A: TelmisartanArm B: No Study Drug
Change in Waist Circumference From Baseline to Week 240.90 (-0.15 to 3.40)0.57 (-3.87 to 5.80)
SecondaryChange in Waist Circumference From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · cm
Change in Waist Circumference From Baseline to Week 48
cmArm A: TelmisartanArm B: No Study Drug
Change in Waist Circumference From Baseline to Week 480.77 (-2.03 to 2.93)-0.08 (-4.95 to 5.05)
SecondaryChange in Waist-to-hip Ratio From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
baseline and week 24
Reported as:
Median · waist cm : hip cm
Change in Waist-to-hip Ratio From Baseline to Week 24
waist cm : hip cmArm A: TelmisartanArm B: No Study Drug
Change in Waist-to-hip Ratio From Baseline to Week 240 (-0.01 to 0.03)0.01 (0 to 0.03)
SecondaryChange in Waist-to-hip Ratio From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
baseline and week 48
Reported as:
Median · waist cm : hip cm
Change in Waist-to-hip Ratio From Baseline to Week 48
waist cm : hip cmArm A: TelmisartanArm B: No Study Drug
Change in Waist-to-hip Ratio From Baseline to Week 480 (-0.01 to 0.02)0.02 (-0.02 to 0.04)
SecondaryChange in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
24 weeks
Reported as:
Median · Percent of CD4+ expressing CD38+HLA-DR+
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24
Percent of CD4+ expressing CD38+HLA-DR+Arm A: TelmisartanArm B: No Study Drug
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 240.20 (-0.60 to 1.50)-1.35 (-2.10 to -0.75)
SecondaryChange in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Time frame:
24 weeks
Reported as:
Median · Percent of CD8+ expressing CD38+HLA-DR+
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24
Percent of CD8+ expressing CD38+HLA-DR+Arm A: TelmisartanArm B: No Study Drug
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 240.60 (-0.60 to 3.00)-0.95 (-2.10 to -0.40)
SecondaryChange in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD4+ expressing CD38+HLA-DR+
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48
Percent of CD4+ expressing CD38+HLA-DR+Arm A: TelmisartanArm B: No Study Drug
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48-0.30 (-0.90 to 1.10)-0.60 (-1.30 to 0.20)
SecondaryChange in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD8+ expressing CD38+HLA-DR+
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48
Percent of CD8+ expressing CD38+HLA-DR+Arm A: TelmisartanArm B: No Study Drug
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48-0.40 (-1.55 to 0.85)-0.20 (-1.80 to 0.90)
SecondaryChange in Expression of CD163+ in Adipose Tissue From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD163+ adipose tissue cells
Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48
Percent of CD163+ adipose tissue cellsArm A: TelmisartanArm B: No Study Drug
Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48-0.19 (-5.55 to 3.76)0.87 (-2.52 to 2.75)
SecondaryChange in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD4+ lymphoid tissue cells
Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.
Percent of CD4+ lymphoid tissue cellsArm A: TelmisartanArm B: No Study Drug
Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.1 (-5.2 to 3.7)-7.8 (-12.3 to 2.1)
SecondaryChange in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD8+ lymphoid tissue cells
Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.
Percent of CD8+ lymphoid tissue cellsArm A: TelmisartanArm B: No Study Drug
Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.-1.19 (-5.3 to 1.5)3.9 (1.0 to 9.2)
SecondaryChange in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD163+ lymphoid tissue cells
Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.
Percent of CD163+ lymphoid tissue cellsArm A: TelmisartanArm B: No Study Drug
Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.-0.13 (-0.81 to 0.81)0.15 (-0.77 to 0.69)
SecondaryChange in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD68+ lymphoid tissue cells
Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.
Percent of CD68+ lymphoid tissue cellsArm A: TelmisartanArm B: No Study Drug
Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.-0.02 (-0.48 to 0.49)0.08 (-1.07 to 0.24)
SecondaryChange in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD38+HLA-DR+ on CD4+ cells
Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.
Percent of CD38+HLA-DR+ on CD4+ cellsArm A: TelmisartanArm B: No Study Drug
Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.-0.33 (-2.55 to 0.87)0.06 (-0.35 to 1.11)
SecondaryChange in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Time frame:
48 weeks
Reported as:
Median · Percent of CD38+HLA-DR+ on CD8+ cells
Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.
Percent of CD38+HLA-DR+ on CD8+ cellsArm A: TelmisartanArm B: No Study Drug
Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.0.13 (-3.95 to 0.63)-0.22 (-0.72 to 0.48)

Adverse events

Collected over From baseline to Week 48.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A: Telmisartan0/29 (0%)3/29 (10.3%)24/29 (82.8%)
Arm B: No Study Drug0/15 (0%)1/15 (6.7%)10/15 (66.7%)
Most frequent serious events
Most frequent serious events
EventArm A: TelmisartanArm B: No Study Drug
Angina unstableCardiac disorders0/291/15
DiarrhoeaGastrointestinal disorders1/290/15
Herpes zoster disseminatedInfections and infestations1/290/15
Hepatic enzyme increasedInvestigations1/290/15
Most frequent other events
Showing 10 of 50
Most frequent other events
EventArm A: TelmisartanArm B: No Study Drug
Blood cholesterol increasedInvestigations13/294/15
Low density lipoprotein increasedInvestigations13/294/15
Blood phosphorus decreasedInvestigations7/293/15
Blood sodium decreasedInvestigations7/292/15
Aspartate aminotransferase increasedInvestigations4/293/15
Alanine aminotransferase increasedInvestigations4/291/15
Blood bilirubin increasedInvestigations4/292/15
Blood glucose increasedInvestigations4/291/15
CoughRespiratory, thoracic and mediastinal disorders4/291/15
NauseaGastrointestinal disorders3/290/15

Baseline characteristics

All Step 2 randomized participants with data available for specific measures.

Age, Continuous
Age, Continuous(years)Arm A: TelmisartanArm B: No Study DrugTotal
Median47 (41 to 51)50 (39 to 52)48 (41 to 52)
Age, Customized
Age, Customized(Participants)Arm A: TelmisartanArm B: No Study DrugTotal
18-29 years022
30-39 years628
40-49 years12315
50-59 years11617
60-69 years022
Sex: Female, Male
Sex: Female, Male(Participants)Arm A: TelmisartanArm B: No Study DrugTotal
Female213
Male271441
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A: TelmisartanArm B: No Study DrugTotal
Hispanic or Latino718
Not Hispanic or Latino221436
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A: TelmisartanArm B: No Study DrugTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American6814
White22729
More than one race101
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Arm A: TelmisartanArm B: No Study DrugTotal
White Non-Hispanic16622
Black Non-Hispanic5813
Hispanic (Regardless of Race)718
More than one race101
IV drug history
IV drug history(Participants)Arm A: TelmisartanArm B: No Study DrugTotal
No History251338
Previous History426
BMI
BMI(kg/m^2)Arm A: TelmisartanArm B: No Study DrugTotal
Median25.4 (23.3 to 29.8)23.7 (21.4 to 26.6)25.0 (22.6 to 28.4)

6 further baseline measures are reported on the registry.

08

Study locations

12 sites
  • UCLA CARE Center CRS (601)
    Los Angeles, California 90035, United States
  • University of Colorado Hospital CRS (6101)
    Aurora, Colorado 80045, United States
  • Massachusetts General Hospital ACTG CRS (101)
    Boston, Massachusetts 02114, United States
  • Washington U CRS (2101)
    Saint Louis, Missouri 63110, United States
  • University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)
    Rochester, New York 14642, United States
  • Unc Aids Crs (3201)
    Chapel Hill, North Carolina 27514, United States
  • Univ. of Cincinnati CRS (2401)
    Cincinnati, Ohio 45267, United States
  • Case CRS (2501)
    Cleveland, Ohio 44106, United States
  • Vanderbilt Therapeutics CRS (3652)
    Nashville, Tennessee 37232, United States
  • Houston AIDS Research Team CRS (31473)
    Houston, Texas 77030, United States
  • University of Washington AIDS CRS (1401)
    Seattle, Washington 98104, United States
  • Puerto Rico-AIDS CRS (5401)
    San Juan, 00935, Puerto Rico
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01928927
Lead sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 27, 2013
Start date
Jan 2014
Primary completion
Mar 2016
Completion
Mar 2016
Results posted
Apr 12, 2017
Last update
Aug 3, 2021

Study contacts

Jordan E. Lake, MD, MSc
study chair · The University of Texas Health Science Center, Houston
Netanya Sandler, MD
study chair · University of Texas Medical Branch at Galveston

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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