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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02652624
Other study ID # GS-US-380-1961
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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