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Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide

NCT04636437 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-07-02

Study results available
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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

  • HIV Infections

Interventions

DRUG

Doravirine 100 Mg

Participants received a 100 mg tablet by mouth daily with or without food.

DRUG

Integrase strand transfer inhibitors

INSTIs were acquired through the standard of care locally.

DRUG

Tenofovir alafenamide/emtricitabine

NRTIs (TAF/FTC) were acquired through the standard of care locally.

DRUG

tenofovir disproxil fumarate/emtricitabine

NRTIs (TDF/FTC) were acquired through the standard of care locally.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • John Koethe · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2024-10-18
Completion
2024-10-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636437 on ClinicalTrials.gov