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OpenTrials
Completed

NCT Number: NCT02603120

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
  • Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
  • HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.
  • Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
  • Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Key Exclusion Criteria:

  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
  • Active tuberculosis infection.
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
  • Females who are pregnant.
  • Females who are breastfeeding.
  • Acute hepatitis in the 30 days prior to study entry.
  • Chronic Hepatitis B Virus (HBV) infection.

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

Treatment and study plan

ABC/DTG/3TC

Drug

600/50/300 mg FDC tablets administered orally once daily without regard to food

Other names: Triumeq®

B/F/TAF

Drug

50/200/25 mg FDC tablets administered orally once daily without regard to food

Other names: Bictegravir (previously referred to as GS-9883)/Emtricitabine/Tenofovir Alafenamide, Biktarvy® [BVY]

ABC/DTG/3TC Placebo

Drug

Tablets administered orally once daily without regard to food

B/F/TAF Placebo

Drug

Tablets administered orally once daily without regard to food

Primary outcomes

  1. Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm

    Time frame: Week 48

    The percentage of participants achieving 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.

Secondary outcomes

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm

    Time frame: Week 48

    The percentage of participants achieving 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.

  2. Change From Baseline in CD4+ Cell Count at Week 48

    Time frame: Baseline; Week 48

  3. Spine Bone Mineral Density (BMD) at Baseline

    Time frame: Baseline

  4. Percentage Change From Baseline in Spine BMD at Week 48

    Time frame: Baseline; Week 48

  5. Hip Bone Mineral Density at Baseline

    Time frame: Baseline

  6. Percentage Change From Baseline in Hip BMD at Week 48

    Time frame: Baseline; Week 48

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Nov 11, 2015
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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