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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 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.

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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.

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

What the Registry Record Tells You About NCT04636437

The ClinicalTrials.gov registry entry for NCT04636437 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (67% lower). The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.