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NCT04636437 · ClinicalTrials.gov registry record · Phase 4
Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide
A Phase 4 study of HIV Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 4
- Development phase
- 147
- Enrollment target
- 20
- Study locations
NCT04636437: Completed Phase 4 study of HIV Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT04636437 is a Phase 4 study of HIV Infections that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 147 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04636437, a Phase 4 study of HIV Infections, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 147 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to determine if people with HIV and obesity taking an antiretroviral treatment regimen containing an integrase strand transfer inhibitor (INSTI) with (tenofovir alafenamide/emtricitabine (TAF/FTC) would either slow their rate of weight gain, or even lose weight, over the span of about 1 year after a switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication) combined with either TAF/TFC or tenofovir disoproxil fumarate (TDF)/FTC.
Primary Outcome
The percentage change is defined as weight at week 48 minus weight at entry, then divided by weight at entry, then multiplied by 100. Mean and confidence interval (CI) come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).
Conditions Studied
Interventions
- DRUG Doravirine 100 Mg
- DRUG Integrase strand transfer inhibitors
- DRUG Tenofovir alafenamide/emtricitabine
- DRUG tenofovir disproxil fumarate/emtricitabine
Study Locations (20)
California
- UCLA CARE Center CRS (601) - Los Angeles
- UCSD Antiviral Research Center CRS (701) - San Diego
- Ucsf Hiv/Aids Crs (801) - San Francisco
- Harbor-UCLA CRS (603) - Torrance
New York
- Weill Cornell Chelsea CRS (7804) - New York
- Columbia Physicians and Surgeons (P&S) CRS (30329) - New York
- Weill Cornell Upton CRS (7803) - New York
- University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) - Rochester
Massachusetts
- Massachusetts General Hospital (MGH) CRS (101) - Boston
- Brigham and Women's Hosp. ACTG CRS (107) - Boston
North Carolina
- Chapel Hill CRS (3201) - Chapel Hill
- Greensboro CRS (3203) - Greensboro
Alabama
- Alabama CRS (31788) - Birmingham
Colorado
- University of Colorado Hospital CRS (6101) - Aurora
District of Columbia
- Whitman-Walker Institute, Inc. CRS (31791) - Washington D.C.
Georgia
- The Ponce de Leon Center CRS (5802) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2021-07-27 |
| Est. Completion | 2024-10-18 |
| Phase | Phase 4 |
What the finished NCT04636437 record still lists
NCT04636437 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (67% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Doravirine 100 Mg is the first listed.
NCT04636437 names 20 study sites across 12 states, led by California, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04636437 about?
NCT04636437 is a clinical study titled "Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide". The purpose of this study was to determine if people with HIV and obesity taking an antiretroviral treatment regimen containing an integrase strand transfer inhibitor (INSTI) with (tenofovir alafenamide/emtricitabine (TAF/FTC) would either slow their rate of weight gain, or even lose weight, over th...
What is the current status of trial NCT04636437?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 147 participants. The study started on 2021-07-27. Estimated completion is 2024-10-18.
What conditions does trial NCT04636437 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04636437?
The interventions under investigation include: Doravirine 100 Mg (DRUG), Integrase strand transfer inhibitors (DRUG), Tenofovir alafenamide/emtricitabine (DRUG), tenofovir disproxil fumarate/emtricitabine (DRUG).
Who is sponsoring clinical trial NCT04636437?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04636437 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04636437's enrollment target sits among peer trials
147 217th of 542 higher than 326 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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