study to evaluate the safety and efficacy of switching from regimens consisting of boosted atazanavir or darunavir plus either emtricitabine/tenofovir or abacavir/lamivudine to bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed hiv-1 infected adults

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (fdc) of bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) versus continuing on a regimen consisting of boosted atazanavir (atv) or darunavir (drv) plus either emtricitabine/tenofovir disoproxil fumarate (ftc/tdf) or abacavir/lamivudine (abc/3tc) in hiv-1 infected adults who are virologically suppressed.


Eligibility criteria:
key inclusion criteria: * currently receiving a once daily antiretroviral regimen consisting of ritonavir or cobicistat boosted atv or drv plus either ftc/tdf or abc/3tc for ≥ 6 months preceding the screening visit * adequate renal function: * estimated glomerular filtration rate ≥ 50 ml/min (≥ 0.83 ml/sec) according to the cockcroft-gault formula * life expectancy ≥ 1 year * currently on a stable regimen for ≥ 6 months preceding the screening visit with documented plasma hiv-1 rna \< 50 copies/ml for ≥ 6 months preceding the screening visit (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml). prior changes in antiretroviral regimen are only allowed due to tolerability issues or for regimen simplification. unconfirmed virologic elevations of ≥ 50 copies/ml (transient detectable viremia, or "blip") prior to screening are acceptable. (if the lower limit of detection of the local hiv-1 rna assay is \< 50 copies/ml \[e.g., \< 20 copies/ml\], the plasma hiv-1 rna level cannot exceed 50 copies/ml on two consecutive hiv-1 rna tests) * have no documented or suspected resistance to ftc, tenofovir, abc or 3tc, including but not limited to the reverse transcriptase resistance mutations k65r and m184v/i * no previous use of any approved or experimental integrase strand transfer inhibitor (insti) key exclusion criteria: * an opportunistic illness indicative of stage 3 hiv diagnosed within the 30 days prior to screening * individuals experiencing decompensated cirrhosis (eg, 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 subject study compliance * a history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous kaposi's sarcoma (ks), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. individuals with biopsy-confirmed cutaneous ks are eligible, but must not have received any systemic therapy for ks within 30 days of day 1 and are not anticipated to require systemic therapy during the study * active, serious infections (other than hiv 1 infection) requiring parenteral 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 individual unsuitable for the study or unable to comply with the dosing requirements * any known allergies to the excipients of b/f/taf fdc or atv, rtv, drv, cobi, ftc/tdf or abc/3tc * females who are pregnant (as confirmed by positive serum pregnancy test) * females who are breastfeeding * acute hepatitis in the 30 days prior to study entry * chronic hepatitis b infection in individuals not on a tdf containing regimen, as determined by either: * positive hepatitis b virus (hbv) surface antigen and negative hbv surface antibody, regardless of hbv core antibody status, at the screening visit * positive hbv core antibody and negative hbv surface antibody, regardless of hbv surface antigen status, at the screening visit * active tuberculosis infection note: other protocol defined inclusion/exclusion criteria may apply.