Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02607956
• Date of registration: 10/11/2015
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
• Scientific title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
• Date of first enrolment: November 11, 2015
• Target sample size: 657
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02607956
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Canada, Dominican Republic, France, Gabon, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Antiretroviral treatment naive (= 10 days of prior therapy with any antiretroviral
agent following a diagnosis of HIV-1 infection) except the use for pre-exposure
prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to
screening

- Plasma HIV-1 RNA levels = 500 copies/mL at screening

- Adequate renal function: Estimated glomerular filtration rate = 30 mL/min (= 0.50
mL/sec) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
to screening

- Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance

- Females who are pregnant (as confirmed by positive serum pregnancy test)

- Females who are breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV-1 Infection

Intervention(s)

Drug: F/TAF

Drug: B/F/TAF

Drug: B/F/TAF Placebo

Drug: F/TAF Placebo

Drug: DTG Placebo

Drug: DTG

Primary Outcome(s)

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 48]

Secondary Outcome(s)

Change From Baseline in CD4+ Cell Count at Week 48 [Time Frame: Baseline; Week 48]

Change From Baseline in log10 HIV-1 RNA at Week 96 [Time Frame: Baseline; Week 96]

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm [Time Frame: Baseline; open-label Week 96]

Change From Baseline in log10 HIV-1 RNA at Week 48 [Time Frame: Baseline; Week 48]

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 144]

Change From Baseline in CD4+ Cell Count at Week 144 [Time Frame: Baseline; Week 144]

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 144]

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm [Time Frame: Baseline; open-label Week 48]

Change From Baseline in log10 HIV-1 RNA at Week 144 [Time Frame: Baseline; Week 144]

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 48]

Change From Baseline in CD4+ Cell Count at Week 48 Open-Label [Time Frame: Baseline; open-label Week 48]

Change From Baseline in CD4+ Cell Count at Week 96 [Time Frame: Baseline; Week 96]

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 96]

Change From Baseline in CD4+ Cell Count at Week 96 Open-Label [Time Frame: Baseline; open-label Week 96]

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 96]

Secondary ID(s)

GS-US-380-1490

2015-003988-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02607956