CClinicalTrials.gg
Status unknownNCT03275701STRUCTRUpdated Sep 7, 2017

Evaluating BMD in Participants ≥50 Years Old Switching From EVG/COBI/FTC/TAF or EVG/COBI/FTC/TDF to ABC/DTG/3TC

An interventional study of Triumeq in Infection, Human Immunodeficiency Virus, sponsored by Mills Clinical Research. Status unknown at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by Mills Clinical Research · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)

Read the detailed description

Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)

To evaluate the impact on BMD, as measured by DEXA over 48 weeks, of switching from an INSTI-based regimen with either TDF or TAF to a regimen of ABC/DTG/3TC (administered as commercial Triumeq) in chronic HIV-infected patients over the age of 50

02

Conditions studied

  • Infection, Human Immunodeficiency Virus
03

Who can participate

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

Inclusion criteria

  1. Documented HIV-1 infection;
  2. At least 50 years of age;
  3. Currently on a stable antiretroviral regimen (for ≥3 months preceding Screening) of either EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild);
  4. HIV is currently suppressed, defined as:

    1. Plasma HIV-1 RNA \<50 c/mL for ≥3 months preceding Screening; AND
    2. Plasma HIV-1 RNA \<50 copies/mL at the Screening assessment; INCL 5. Documentation that the participant is negative for the human leukocyte antigen (HLA)-B*5701 allele.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant, breastfeeding, or planning to become pregnant during the study period;
  2. Bilateral hip replacement;
  3. Exceeds weight limit for DEXA equipment (i.e., weighs >350 lbs or >159 kg);
  4. History or presence of allergy to the study treatment (Triumeq) or any of its components (to ABC, DTG, or 3TC);
  5. Active Centers for Disease Control and Prevention (CDC) Category C HIV-1 disease (see Section 17.1 for definition), with the exception of cutaneous Kaposi's sarcoma, not requiring systemic therapy and historic CD4+ cell counts of \<200 cells/mm3;
  6. Positive for hepatitis B virus surface antigen (HBsAg) at Screening;
  7. Ongoing malignancies (other than localized malignancies, such as cutaneous Kaposi's sarcoma, basal cell carcinoma, cervical intraepithelial neoplasia);
  8. Significant suicidal risk in the investigator's opinion;
  9. Metabolic disease;
  10. Treatment with HIV immunotherapeutic vaccine within 90 days of Screening;
  11. Radiation, cytotoxic chemotherapy, or any immunomodulator (that alters immune responses) within 28 days of Screening;
  12. Exposure to any experimental drug or vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to first dose of study treatment on Day 1;
  13. History of use of only mono or dual NRTI therapy prior to starting combination ART for the treatment of HIV infection (except that prior NRTI use for the purpose of pre-exposure prophylaxis [PrEP] or postexposure prophylaxis [PEP] is not excluded);
  14. Became HIV-positive (i.e., had a detectable plasma HIV-1 viral load) while taking PrEP or PEP;
  15. Documented resistance to any component of the study treatment (ABC, DTG, or 3TC) as indicated by either:

    1. Historical genotype in the participant's medical record; OR
    2. Genotype obtained by GenoSure Archive evaluation at Screening;
  16. Any verified screening Grade 4 laboratory abnormality that in the investigator's opinion is clinically significant;
  17. Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
  18. Either of the following liver chemistry elevations:

    1. Alanine amintotransferase (ALT) ≥5 x the upper limit of normal (ULN); OR
    2. ALT ≥3 x ULN and bilirubin ≥1.5 x ULN (with >35% direct bilirubin);
  19. Creatinine clearance (CrCl) of \<50 mL/min (calculated by CockroftGault equation)
  20. QT interval corrected for heart rate according to Bazett's formula (QTcB) ≥450 msec or QTcB ≥480 msec for participants with bundle branch block;
  21. Any other condition or substance use that in the opinion of the investigator places the participants at undue risk from participation in the study or that may negatively impact the integrity of the study analyses.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Triumeq

    Single Arm, Open Label

    Drug: Triumeq

Interventions

  • DrugTriumeq

    Open Label, Switch to Triumeq (ABC/DTG/3TC)

05

What researchers measure

Primary outcomes

  1. Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)

    Time frame: 48 Weeks

  2. Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)

    Time frame: 48 Weeks

Other outcomes

  1. Change from Baseline in bone biomarkers for individuals switching to ABC/DTG/3TC

    Time frame: 96 Weeks

  2. Change from baseline in bone mineral density (in lumbar spine and total hip) assessed by T-scores and Z-scores from Baseline in individuals switching to ABC/DTG/3TC

    Z-score = (Patient's BMD - expected BMD) / SD; T-score = (BMD-Reference BMD)/SD Units are numerical in value. BMD)/SD Units are numerical in value.

    Time frame: 96 Weeks

  3. Number of adverse events (including long-term virologic/immunologic responses, abnormal laboratory values, or untoward medical conditions) for individuals switching to ABC/DTG/3TC

    Time frame: 96 Weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03275701
Lead sponsor
Mills Clinical Research
Collaborators
ViiV Healthcare
Responsible party
Anthony Mills MD (Clinical Research Director, Mills Clinical Research) — Principal investigator
First posted
Sep 7, 2017
Start date
Jul 2016
Primary completion
Oct 2019 (estimated)
Completion
Nov 2019 (estimated)
Last update
Sep 7, 2017

Study contacts

Anthony Mills, MD
Contact
tony.mills@millsclinicalresearch.com
310-550-2271
Ron Knight
Contact
ron.knight@millsclinicalresearch.com
310-550-2271
Anthony M Mills, MD
principal investigator · Mills Clinical Research

Oversight

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

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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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