A Phase 3, Randomized, Open-Label 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 GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

INTERVENTION:

Product Code: GS‐9883/F/TAF Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

GS‐9883 Current Sponsor code: GS‐9883 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed

INN:

EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed

INN:

Tenofovir Alafenamide CAS Number: 379270‐37‐8 Other descriptive name: TENOFOVIR ALAFENAMIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐

CONDITION:

Human Immunodeficiency Virus (HIV‐1) Infection ; MedDRA version: 18.1 Level: LLT Classification code 10068341 Term: HIV‐1 infection System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02]

PRIMARY OUTCOME:

Main Objective: To evaluate the efficacy of switching to a FDC of GS‐9883/F/TAF versus continuing on a regimen consisting of boosted atazanavir or darunavir plus either FTC/TDF or ABC/3TC in HIV‐1 infected adult subjects who are virologically suppressed as determined by the proportion of subjects with virologic failure (HIV‐1 RNA >= 50 copies/mL) at Week 48 Primary end point(s): The proportion of subjects with virologic failure (HIV‐1 RNA >= 50 copies/mL) at Week 48 as defined by the modified US FDA snapshot algorithm Secondary Objective: To evaluate the safety and tolerability of the two treatment groups through Week 48 Timepoint(s) of evaluation of this end point: Week 48

SECONDARY OUTCOME:

Secondary end point(s): ‐ The proportion of subjects with HIV‐1 RNA < 50 copies/mL at Week 48 as defined by the US FDA snapshot algorithm; ; ‐ The change from baseline in CD4+ cell counts at Week 48 Timepoint(s) of evaluation of this end point: Week 48

INCLUSION CRITERIA:

1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2) Aged 18 years or older 3) Currently receiving antiretroviral regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for 6 months or more preceding the screening visit 4) HIV RNA < 50 copies/mL at the screening visit 5) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant) 6) Adequate renal function 7) Hepatic transaminases (AST and ALT) <= 5 x upper limit of normal (ULN) 8) Total bilirubin <= 1.5 mg/dL (<= 26 umol/L), or normal direct bilirubin 9) Adequate hematologic function (absolute neutrophil count >= 750/mm3 (>= 0.75 GI/L); platelets >= 50,000/mm3 (>= 50 GI/L); hemoglobin >= 8.5 g/dL (>= 85 g/L)) 10) Serum amylase <= 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is <= 5 × ULN)

Epistemonikos ID.: 63eb4fef50510fe238ae1042ad6636cf374fa563


First added on: Aug 23, 2024