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

February 18, 2020 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

472

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic
      • Santo Domingo, Dominican Republic, 10514
  • Puerto Rico
      • San Juan, Puerto Rico, 00909-1711
  • Russian Federation
      • Barnaul, Russian Federation, 656010
      • Ekaterinburg, Russian Federation, 620102
      • Irkutsk, Russian Federation, 664043
      • Khabarovsk, Russian Federation, 680031
      • Koltsovo, Russian Federation, 630559
      • Krasnodar, Russian Federation, 350015
      • Krasnoyarsk, Russian Federation, 660049
      • Lipetsk, Russian Federation, 398043
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 105275
      • Nizhniy Novgorod, Russian Federation, 603950
      • Saint Petersburg, Russian Federation, 190103
      • Saint Petersburg, Russian Federation, 196645
      • Saint-Petersberg, Russian Federation, 190020
      • Saint-Petersburg, Russian Federation, 191167
      • Volgograd, Russian Federation, 400010
      • Voronezh, Russian Federation, 394065
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50200
      • Khon Kaen, Thailand, 40002
      • Nonthaburi, Thailand, 11000
  • Uganda
      • Kampala, Uganda
  • United States
    • Connecticut
      • Stamford, Connecticut, United States, 6902
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Pierce, Florida, United States, 34982
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33133
      • Orlando, Florida, United States, 32803-1851
      • Tampa, Florida, United States, 33607
      • Tampa, Florida, United States, 33614
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Decatur, Georgia, United States, 30033
      • Macon, Georgia, United States, 31201
      • Savannah, Georgia, United States, 31401
    • Massachusetts
      • Springfield, Massachusetts, United States, 01105
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • New Jersey
      • Newark, New Jersey, United States, 07102
    • New York
      • Bronx, New York, United States, 10467
      • Great Neck, New York, United States, 11021
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
      • Durham, North Carolina, United States, 27710
      • Huntersville, North Carolina, United States, 28078
    • Texas
      • Bellaire, Texas, United States, 77401
      • Dallas, Texas, United States, 75219
      • Dallas, Texas, United States, 75208
      • Fort Worth, Texas, United States, 76104
      • Harlingen, Texas, United States, 78550
      • Houston, Texas, United States, 77004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B/F/TAF
Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks.
Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Other Names:
  • Biktarvy®
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.
Drug: E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily with food
Other Names:
  • Genvoya®
Drug: E/C/F/TDF
150/150/200/300 mg FDC administered orally once daily with food
Other Names:
  • Stribild®
Drug: ATV
ATV 300 mg capsules administered orally once daily with food
Other Names:
  • Reyataz®
Drug: RTV
RTV 100 mg tablets administered orally once daily with food
Other Names:
  • Norvir®
Drug: FTC/TDF
200/300 mg tablet administered orally once daily with food
Other Names:
  • Truvada®
Experimental: Extension Phase
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
Other Names:
  • Biktarvy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in CD4+ Cell Count at Week 48
Time Frame: Baseline; Week 48
Baseline; Week 48
Percentage 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2016

Primary Completion (Actual)

October 9, 2017

Study Completion (Actual)

November 26, 2018

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-380-1961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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