Status:
UNKNOWN
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults
Lead Sponsor:
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Collaborating Sponsors:
Brigham and Women's Hospital
Harvard Medical School (HMS and HSDM)
Conditions:
HIV-1-infection
Antiretroviral Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 viro...
Detailed Description
The second generation integrase strand transfer inhibitors (INSTIs) dolutegravir (DTG) and bictegravir (BIC) are widely prescribed for the treatment of HIV, due to their favorable tolerability and tox...
Eligibility Criteria
Inclusion
- 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) \</=5X upper limit of normal (ULN)
- No active TB
- Women of childbearing age must agree to take reliable contraception
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT04311957
Start Date
September 1 2020
End Date
November 30 2022
Last Update
August 3 2020
Active Locations (1)
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1
GHESKIO
Port-au-Prince, Haiti