Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

HIV-1 Infection Clinical Trial

Official title:

A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652624
• Other study ID #: GS-US-380-1961
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2016
• Est. completion date: November 26, 2018

Study information

• Verified date: November 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: November 26, 2018
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

Medically stable HIV-1 infected women who meet the following criteria:

• Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111.

• Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for = 12 consecutive weeks preceding the Screening visit

• Documented plasma HIV-1 RNA levels < 50 copies/mL for = 12 weeks preceding the Screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA

= 50 copies/mL followed by re-suppression to < 50 copies/mL is allowed

• HIV-1 RNA <50 copies/mL at screening

• Estimated glomerular filtration rate (eGFR) = 50 mL/min (= 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit

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

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily with food
• E/C/F/TDF
150/150/200/300 mg FDC administered orally once daily with food
• ATV
ATV 300 mg capsules administered orally once daily with food
• RTV
RTV 100 mg tablets administered orally once daily with food
• FTC/TDF
200/300 mg tablet administered orally once daily with food
• B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Dominican Republic,  Puerto Rico,  Russian Federation,  Thailand,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With HIV-1 RNA = 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm	The percentage of participants with HIV-1 RNA = 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Change From Baseline in CD4+ Cell Count at Week 48		Baseline; Week 48