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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02652624
First Posted: January 12, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This study will 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.

Condition Intervention Phase
HIV-1 Infection Drug: E/C/F/TAF Drug: E/C/F/TDF Drug: ATV Drug: RTV Drug: FTC/TDF Drug: B/F/TAF Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]

Secondary Outcome Measures:
  • Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]

Enrollment: 471
Actual Study Start Date: February 1, 2016
Estimated Study Completion Date: October 2018
Primary Completion Date: October 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B/F/TAF

Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks.

Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional weeks.

Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Active Comparator: Baseline Regimen

Participants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks.

Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional weeks.

Drug: E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily with food
Other Name: Genvoya®
Drug: E/C/F/TDF
150/150/200/300 mg FDC administered orally once daily with food
Other Name: Stribild®
Drug: ATV
ATV 300 mg capsules administered orally once daily with food
Other Name: Reyataz®
Drug: RTV
RTV 100 mg tablets administered orally once daily with food
Other Name: Norvir®
Drug: FTC/TDF
200/300 mg tablet administered orally once daily with food
Other Name: Truvada®
Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652624


  Show 56 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02652624     History of Changes
Other Study ID Numbers: GS-US-380-1961
First Submitted: January 8, 2016
First Posted: January 12, 2016
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emtricitabine
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents