The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.
Name: B/F/TAF
Description: 50/200/25 mg FDC tablets administered orally once daily without regard to foodType: DrugB/F/TAF Stay on Baseline Regimen
Name: NRTIs
Description: NRTIs could include one of the following: Abacavir (ABC) Didanosine (ddI) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4T) Tenofovir alafenamide (TAF) Tenofovir disoproxil fumarate (TDF) Zidovudine (ZDV or AZT) NRTIs will be administered as prescribed until Week 24 without regard to food.Type: DrugStay on Baseline Regimen
Name: Third Agent
Description: Third agent could include one of the following: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Delavirdine (DLV) Efavirenz (EFV) Nevirapine (NVP) Rilpivirine (RPV) Integrase inhibitors Dolutegravir (DTG) Elvitegravir (EVG) Raltegravir (RAL) Protease inhibitors (PIs) Atazanavir (ATV) Darunavir (DRV) Lopinavir Nelfinavir NFV) Saquinavir (SQV) Tipranavir (TPV) Third agents will be administered as prescribed without regard to food. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir.Type: DrugStay on Baseline Regimen
Allocation: Randomized
Parallel Assignment
There are 8 SNPs
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V --- --- M41L --- --- D67N ---
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT - No desire to switch from current antiretrovirals (ARVs) - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance - Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements - Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to randomization - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- M41L --- --- D67N ---
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q ---
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT - No desire to switch from current antiretrovirals (ARVs) - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance - Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements - Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to randomization - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q ---
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q --- --- K65R ---
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT - No desire to switch from current antiretrovirals (ARVs) - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance - Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements - Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to randomization - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q --- --- K65R ---
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V --- --- M41L --- --- D67N --- --- K70R ---
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT - No desire to switch from current antiretrovirals (ARVs) - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance - Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements - Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to randomization - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- M41L --- --- D67N --- --- K70R ---
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W ---
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT - No desire to switch from current antiretrovirals (ARVs) - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance - Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements - Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to randomization - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- M41L --- --- D67N --- --- K70R --- --- L210W ---
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V ---
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V --- --- M41L ---
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT - No desire to switch from current antiretrovirals (ARVs) - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance - Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements - Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to randomization - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- M41L ---
- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded. --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT - No desire to switch from current antiretrovirals (ARVs) - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance - Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements - Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to randomization - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---