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CompletedNCT01529749Updated Aug 2, 2019Results posted

Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated

A Phase 4 interventional study of EFV/FTC/TDF + Losartan and EFV/FTC/TDF in HIV-1 Infection, sponsored by Felipe Garcia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-02.

Sponsored by Felipe Garcia · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows:

Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)

The allocation will take place in two phases:

Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan

If losartan arm shows benefits we will proceed to the second phase:

Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.

Patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.

02

Conditions studied

  • HIV-1 Infection

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 2,436 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

This is the only study on the registry with Felipe Garcia as lead sponsor.

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

Inclusion criteria

  1. Patients older than 18 years.
  2. Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL \<37 copies) for at least 48 weeks.
  3. Nadir CD4 +> 250 cells/mm3.
  4. Patients, properly informed, give their written consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Criteria for patients with AIDS.
  2. Patients with active opportunistic diseases.
  3. Patients coinfected with HCV.
  4. Patients without tonsillar tissue.
  5. Treatment with other drugs receptor antagonists or angiotensin II converting enzyme inhibitors, angiotensin II.
  6. Kidney failure.(Glomerular Filtration Rate (GFR \< 60 mL/mn)
  7. Severe liver failure (PT> 60% ).
  8. Pregnant women
  9. Known hypersensitivity or contraindication to any study drug.
  10. determination of blood pressure (BP) \<100/60 mmHg
  11. Hyponatremia with serum Na numbers \<132 Meq / l
  12. History of chronic vomiting the last 6 months
  13. History of chronic diarrhea the last 6 months
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    EFV/FTC/TDF

    Drug: EFV/FTC/TDF

  • Experimental
    EFV/FTC/TDF + Losartan

    Drug: EFV/FTC/TDF + Losartan

  • Experimental
    FTC/TDF + MK-0518

    Drug: FTC/TDF + MK-0518

  • Experimental
    FTC/TDF+MK-0518+Losartan

    Drug: FTC/TDF+MK-0518+Losartan

Interventions

  • DrugEFV/FTC/TDF + Losartan

    EFV/FTC/TDF --\> oral, 600/200/245 mg, od Losartan --\> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.

  • DrugEFV/FTC/TDF

    600/200/245 mg, od, oral

  • DrugFTC/TDF + MK-0518

    FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral

  • DrugFTC/TDF+MK-0518+Losartan

    FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral Losartan --\> -\> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

06

What researchers measure

Primary outcomes

  1. Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.

    Time frame: 48 weeks

Secondary outcomes

  1. Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.

    Time frame: 48 weeks

  2. Proportion of Patients With Changes in the Levels of CRP in Different Groups.

    Time frame: 48 weeks

  3. Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.

    Time frame: 48 weeks

  4. Proportion of Patients With Increased CD4 in Peripheral Blood.

    Time frame: 48 weeks

  5. Proportion of Patients With Increased CD4 in Lymphatic Tissue.

    Time frame: week 48

  6. Proportion of Patients With Undetectable Plasma Viral Load in Different Groups

    Time frame: 48 weeks

  7. Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups

    Time frame: week 48

  8. Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.

    Time frame: 48 weeks

  9. Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.

    Time frame: 48 weeks

  10. Proportion of Patients With Changes in Levels of Metalloproteinases

    Time frame: 48 weeks

  11. Proportion of Patients With Changes in Levels of beta2-microglobulin.

    Time frame: 48 weeks

  12. Proportion of Patients With Changes in Levels of CSF Cells.

    Time frame: 48 weeks

  13. Proportion of Patients With Changes in Levels of Proteins.

    Time frame: 48 weeks

  14. Proportion of Patients With Improvement in Neuropsychological Test

    Time frame: 48 weeks

  15. Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.

    Time frame: up to 48 weeks

  16. Changes in CD4 CD38+ HLADR+ (%)

    Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline)

    Time frame: 0, 48 weeks

07

Results

Posted Aug 2, 2019

Participant flow

Participant flow — Overall Study
MilestoneEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Started12121212
Completed12101010
Not completed0222
Withdrew: Lost to follow-up0110
Withdrew: Physician decision0001
Withdrew: Withdrawal by subject0110
Withdrew: Protocol violation0001

Outcome measures

PrimaryProportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Changes in the Levels of IL-6 in Different Groups.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Changes in the Levels of CRP in Different Groups.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Changes in the Levels of CRP in Different Groups.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Changes in the Levels of CRP in Different Groups.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Changes in the Levels of D-dimer in Different Groups.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Increased CD4 in Peripheral Blood.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Increased CD4 in Peripheral Blood.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Increased CD4 in Peripheral Blood.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Increased CD4 in Lymphatic Tissue.
Time frame:
week 48
Reported as:
Number · participants
Proportion of Patients With Increased CD4 in Lymphatic Tissue.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Increased CD4 in Lymphatic Tissue.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Undetectable Plasma Viral Load in Different Groups
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups12101010
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
Time frame:
week 48
Reported as:
Number · participants
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups12101010
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryChanges in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
Time frame:
48 weeks
Reported as:
Median · ratio
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
ratioEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.-0.03 (-0.2 to 0.3)0.04 (-0.2 to 0.3)0.36 (0.0 to 0.5)0.37 (0.2 to 0.6)
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Kruskal-Wallis · p = 0.01
SecondaryProportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Changes in Levels of Metalloproteinases
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Changes in Levels of Metalloproteinases
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Changes in Levels of Metalloproteinases0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Changes in Levels of beta2-microglobulin.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Changes in Levels of beta2-microglobulin.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Changes in Levels of beta2-microglobulin.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Changes in Levels of CSF Cells.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Changes in Levels of CSF Cells.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Changes in Levels of CSF Cells.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Changes in Levels of Proteins.
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Changes in Levels of Proteins.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Changes in Levels of Proteins.0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryProportion of Patients With Improvement in Neuropsychological Test
Time frame:
48 weeks
Reported as:
Number · participants
Proportion of Patients With Improvement in Neuropsychological Test
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Proportion of Patients With Improvement in Neuropsychological Test0000
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 1
SecondaryNumber of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
Time frame:
up to 48 weeks
Reported as:
Number · participants
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
participantsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.6636
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Chi-squared, Corrected · p = 0.49
SecondaryChanges in CD4 CD38+ HLADR+ (%)

Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline)

Time frame:
0, 48 weeks
Reported as:
Median · percentage of CD4 T cells
Changes in CD4 CD38+ HLADR+ (%)
percentage of CD4 T cellsEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Changes in CD4 CD38+ HLADR+ (%)2.3 (1.4 to 5.5)4 (2.6 to 4.4)1.8 (1 to 2.5)2.2 (1.6 to 3)
Statistical analysis
  • EFV/FTC/TDF vs EFV/FTC/TDF + Losartan vs FTC/TDF + MK-0518 vs FTC/TDF+MK-0518+Losartan · Kruskal-Wallis · p = 0.02

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
EFV/FTC/TDF0/12 (0%)0/12 (0%)6/12 (50%)
EFV/FTC/TDF + Losartan0/10 (0%)0/10 (0%)6/10 (60%)
FTC/TDF + MK-05180/10 (0%)0/10 (0%)3/10 (30%)
FTC/TDF+MK-0518+Losartan0/10 (0%)0/10 (0%)6/10 (60%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventEFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+Losartan
Hepatitis CInfections and infestations0/120/101/102/10
Sexual transmitted diseasesInfections and infestations1/120/100/102/10
Post lumbar puncture headacheNervous system disorders1/121/100/101/10
RashSkin and subcutaneous tissue disorders0/121/100/100/10
High Blood PressureVascular disorders0/121/100/100/10
Liver tests abonormalitiesHepatobiliary disorders1/121/100/100/10
AstheniaPsychiatric disorders0/121/100/100/10
DiarrhoeaGastrointestinal disorders0/121/100/100/10
InsomniaPsychiatric disorders0/120/101/100/10
HeadacheNervous system disorders0/120/101/100/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)EFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+LosartanTotal
<=18 years00000
Between 18 and 65 years1210101042
>=65 years00000
Age, Continuous
Age, Continuous(years)EFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+LosartanTotal
Median40 (33 to 48)43 (35 to 49)43 (42 to 51)35 (32 to 48)41 (33 to 49)
Sex: Female, Male
Sex: Female, Male(Participants)EFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+LosartanTotal
Female12003
Male118101039
Region of Enrollment
Region of Enrollment(participants)EFV/FTC/TDFEFV/FTC/TDF + LosartanFTC/TDF + MK-0518FTC/TDF+MK-0518+LosartanTotal
Spain1210101042
08

Study locations

1 site
  • Hospital Clinic
    Barcelona, 08036, Spain
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01529749
Lead sponsor
Felipe Garcia
Responsible party
Felipe Garcia (Dr, Hospital Clinic of Barcelona) — Sponsor-investigator
First posted
Feb 9, 2012
Start date
Feb 2012
Primary completion
Mar 2012
Completion
Feb 2016
Results posted
Aug 2, 2019
Last update
Aug 2, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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