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Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults

NCT04311957 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2020-08-03

No results posted yet for this study

Summary

This randomized trial compares the efficacy of switching to a fixed-dose combination of B/F/TAF versus continuing a boosted protease inhibitor (bPI) regimen in HIV-1 infected participants who are virologically suppressed (HIV-1 RNA \<200 copies) on a second-line bPI regimen. Half of participants will receive B/F/TAF and half will continue a bPI regimen. The hypothesize is that B/F/TAF will have efficacy that is non-inferior to the boosted PI regimen.

Conditions

Interventions

DRUG

Continuation of boosted PI

Continuation of the same second-line regimen taken prior to entry: LPVr 400 mg/100 mg BID or ATVr 300 mg/100 mg QD + 2 NRTIs

DRUG

B/F/TAF

Single-tablet, fixed dose combination of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF) administered orally, once daily.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Analysis Group, Inc.

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

    lead OTHER

Principal Investigators

  • Patrice Severe, MD · Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

  • Serena Koenig, MD · Brigham and Women's Hospital/Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-05-31
Completion
2022-11-30
FDA Drug
Yes

Countries

  • Haiti

Study Locations

More Related Trials

Entities

Diseases

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 NCT04311957 on ClinicalTrials.gov