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NCT Number: NCT02397694

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.

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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 2

Primary location

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)
  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
  • Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
  • CD4+ cell count ≥ 200 cells/µL at screening

Key Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
  • Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
  • Chronic hepatitis B virus (HBV) infection
  • Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial

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

Treatment and study plan

BIC

Drug

75 mg tablet administered orally once daily

Other names: GS-9883

F/TAF

Drug

200/25 mg FDC tablet administered orally once daily

DTG

Drug

50 mg tablet administered orally once daily

Other names: Tivicay®

BIC Placebo

Drug

Tablet administered orally once daily

DTG Placebo

Drug

Tablet administered orally once daily

B/F/TAF

Drug

50/200/25 mg FDC tablet administered orally once daily

Primary outcomes

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

    Time frame: Week 24

    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 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 Determined by the FDA-defined Snapshot Algorithm at Week 12

    Time frame: Week 12

    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 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. Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48

    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.

  3. The Change From Baseline in log10 HIV-1 RNA at Week 12

    Time frame: Baseline; Week 12

  4. The Change From Baseline in log10 HIV-1 RNA at Week 24

    Time frame: Baseline; Week 24

  5. The Change From Baseline in log10 HIV-1 RNA at Week 48

    Time frame: Baseline; Week 48

  6. The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12

    Time frame: Baseline; Week 12

  7. The Change From Baseline in CD4+ Cell Count at Week 24

    Time frame: Baseline; Week 24

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

    Time frame: Baseline; Week 48

  9. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase

    Time frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)

  10. Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase

    Time frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)

  11. PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

    Cmax is the maximum observed plasma concentration of the drug.

  12. PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

    Tmax was defined as the time to Cmax.

  13. PK Parameter:Ctau for BIC, FTC and TFV

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

    Ctau was defined as the observed drug concentration at the end of the dosing interval.

  14. PK Parameter: AUCtau for BIC, FTC, TAF, and TFV

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

    AUCtau is defined as the area under the concentration-time curve of the drug over time.

  15. PK Parameter: t1/2 of BIC, FTC, TAF, and TFV

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

    t1/2 was defined as the terminal elimination half-life of the drug

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Important dates

Study start
2015
Primary completion
2015
Study completion
2019
First posted
Mar 25, 2015
Registry last updated
Apr 7, 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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