HIV-1-infection Clinical Trial
Official title:
A Randomized Non-Inferiority Trial to Compare the Efficacy of Switching From Protease-Inhibitor Based Second-Line Therapy to Bictegravir-Tenofovir Alafenamide-Emtricitabine in Virologically Suppressed Adults in Haiti
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.
Status | Not yet recruiting |
Enrollment | 386 |
Est. completion date | November 30, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) </=5X upper limit of normal (ULN) - 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 |
Country | Name | City | State |
---|---|---|---|
Haiti | GHESKIO | Port-au-Prince |
Lead Sponsor | Collaborator |
---|---|
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic | Analysis Group, Inc., Brigham and Women's Hospital, Harvard Medical School, Weill Medical College of Cornell University |
Haiti,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Virologic failure - 200 Copies/mL cut-off | Proportion of participants with HIV-1 RNA at least 200 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm | Week 48 | |
Secondary | Virologic failure - 50 Copies/mL cut-off | Proportion of participants with HIV-1 RNA at least 50 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm | Week 48 | |
Secondary | Virologic failure - 1000 Copies/mL cut-off | Proportion of participants with HIV-1 RNA at least 1000 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm | Week 48 | |
Secondary | Tolerability as measured by discontinuing medication | Proportion of participants discontinuing therapy for drug-related adverse events | Entry to 48 weeks | |
Secondary | Adverse events | Proportion of participants with 1 or more NIH Division of AIDS Grade 3 or 4 adverse events (at least 1 grade increase from baseline) | Entry to 48 weeks | |
Secondary | Change in cholesterol | Median change in cholesterol | Entry to 48 weeks | |
Secondary | Change in weight | Median change in weight in kilograms | Entry to 48 weeks | |
Secondary | Change in body mass index | Median change in body mass index (weight in kilograms divided by the square of height in meters) | Entry to 48 weeks | |
Secondary | Weight gain of 10% or greater | Proportion of participants with weight gain of at least 10% (in kilograms) | Entry to 48 weeks | |
Secondary | Change in waist circumference | Median change in waist circumference | Entry to 48 weeks | |
Secondary | Waist to hip ratio | Median change in waist to hip ratio | Entry to 48 weeks | |
Secondary | Adherence | Median adherence as measured by pharmacy refill records | Entry to 48 weeks |
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