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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Harvard Medical School (HMS and HSDM) | OTHER |
| Analysis Group, Inc. | INDUSTRY |
| Weill Medical College of Cornell University |
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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.
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 toxicity profile, durable efficacy, and high barrier to resistance. However, there are limited data to guide the management of patients who are already virally suppressed on a second-line bPI regimen.
Though bPIs have a high barrier to resistance and durable virologic efficacy, they have several important drug-drug interactions, are associated with unfavorable long-term metabolic effects, and may be poorly tolerated. For these reasons, a second-generation INSTI would be preferable to a boosted PI regimen, as long INSTIs are demonstrated to have non-inferior efficacy for patients who are already suppressed on a second-line bPI regimen.
In the proposed study, the efficacy of continuing the bPI regimen will be compared to switching to B/F/TAF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boosted PI Group | Active Comparator | Continuation of the same second-line regimen taken prior to entry: This includes either Lopinavir/ritonavir (LPVr) 400 mg/100 mg BID or Atazanavir/ritonavir (ATV/r) 300 mg/100 mg QD plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). |
|
| B/F/TAF Group | Experimental | Combination tablet of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF) administered orally, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuation of boosted PI | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Virologic failure - 1000 Copies/mL cut-off |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrice Severe, MD | Contact | 718-962-4585 | patsevere@gheskio.org | |
| Serena Koenig, MD | Contact | 617-413-4090 | skoenig@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patrice Severe, MD | Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic | Principal Investigator |
| Serena Koenig, MD | Brigham and Women's Hospital/Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHESKIO | Port-au-Prince | Haiti |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40883049 | Derived | Severe P, Pierre S, Homeus F, Marc JB, Trevisi L, Aristhomene ML, Bernadin GR, Lavoile K, Rivera V, Duchatellier CF, Joseph MJ, Wu J, Rouzier V, Preval F, Jean E, Bernadin J, Zion A, Pierre Louis Forestal G, Avila-Rios S, Garcia Morales C, Zhang A, Israelski D, Apollon A, Dumont E, Fox E, Cremieux PY, Pape JW, Collins SE, Liautaud B, Sax PE, Koenig SP. Bictegravir, emtricitabine, and tenofovir alafenamide versus ritonavir-boosted protease inhibitor-based antiretroviral therapy in people with HIV and viral suppression on second-line therapy in Haiti: an open-label, randomised, non-inferiority trial. Lancet HIV. 2025 Sep;12(9):e616-e626. doi: 10.1016/S2352-3018(25)00130-4. |
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| OTHER |
Participants will be randomized to the B/F/TAF or continuation bPI group in a 1:1 ratio.
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Open label study.
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| B/F/TAF | Drug | Single-tablet, fixed dose combination of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF) administered orally, once daily. |
|
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 |
| Tolerability as measured by discontinuing medication | Proportion of participants discontinuing therapy for drug-related adverse events | Entry to 48 weeks |
| 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 |
| Change in cholesterol | Median change in cholesterol | Entry to 48 weeks |
| Change in weight | Median change in weight in kilograms | Entry to 48 weeks |
| 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 |
| Weight gain of 10% or greater | Proportion of participants with weight gain of at least 10% (in kilograms) | Entry to 48 weeks |
| Change in waist circumference | Median change in waist circumference | Entry to 48 weeks |
| Waist to hip ratio | Median change in waist to hip ratio | Entry to 48 weeks |
| Adherence | Median adherence as measured by pharmacy refill records | Entry to 48 weeks |