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COMPLETED Phase 4

Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide

NCT04636437 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 147 participants
Start Date 2021-07-27
Est. Completion 2024-10-18
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04636437

The ClinicalTrials.gov registry entry for NCT04636437 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04636437 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, New York, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04636437?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial