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

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
• Collaborators: Analysis Group, Inc.; Brigham and Women's Hospital; Harvard Medical School; Harvard Medical School (HMS and HSDM); Weill Medical College of Cornell University
• Treatments: Emtricitabine; HIV Protease Inhibitors; Protease Inhibitors; Tenofovir

Criteria

Inclusion Criteria:

• The ability and willingness to give informed consent.

• Age ≥18 years

• History of meeting WHO criteria for immunologic or virologic failure after receipt of a first-line treatment regimen for ≥6 months

• Currently receiving a second-line ART regimen including either ATVr or LPVr + 2 NRTIs for ≥6 months

• At least one HIV-1 RNA <200 copies/mL within 12 months prior to enrollment, and no HIV-1 RNA of at least 200 copies/mL during this period.

• Plasma HIV-1 RNA <200 copies/mL at Screening Visit.

• eGFR ≥ 50 mL/min according to the MDRD study equation for creatinine clearance

• Hepatic transaminases (AST and ALT)
• No active TB

• Women of childbearing age must agree to take reliable contraception

Exclusion Criteria:

• Active World Health Organization Stage 3 or 4 condition

• Treatment with an INSTI in the past

• Gap in care of at least one month in the prior six months

• Current alcohol or substance use judged by investigator to potentially interfere with participant study compliance

• History of poor adherence, that in the opinion of the investigator, would potentially interfere with study compliance

• Pregnant or breastfeeding at screening visit

• Planning to transfer care