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

NCT02397694 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GS-US-141-1475
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

HIV-1 Infection

Keywords

Adult; HIV; naive

Outcome Measures

Primary Outcomes (1)

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

  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.

  Week 24

Secondary Outcomes (15)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12

  Week 12

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48

  Week 48

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

  Baseline; Week 12

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

  Baseline; Week 24

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

  Baseline; Week 48

Study Arms (3)

BIC + F/TAF

EXPERIMENTAL

Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.

Drug: BIC; Drug: F/TAF; Drug: DTG Placebo; Drug: B/F/TAF

DTG + F/TAF

ACTIVE COMPARATOR

Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.

Drug: F/TAF; Drug: DTG; Drug: BIC Placebo; Drug: B/F/TAF

Open Label Extension Phase

EXPERIMENTAL

After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.

Drug: B/F/TAF

Interventions

BIC DRUG

75 mg tablet administered orally once daily

Also known as: GS-9883

BIC + F/TAF

F/TAF DRUG

200/25 mg FDC tablet administered orally once daily

BIC + F/TAF; DTG + F/TAF

DTG DRUG

50 mg tablet administered orally once daily

Also known as: Tivicay®

DTG + F/TAF

BIC Placebo DRUG

Tablet administered orally once daily

DTG + F/TAF

DTG Placebo DRUG

Tablet administered orally once daily

BIC + F/TAF

B/F/TAF DRUG

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

BIC + F/TAF; DTG + F/TAF; Open Label Extension Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (21)

Unknown Facility

Phoenix, Arizona, 85012, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

Los Angeles, California, 90069, United States

Location

Unknown Facility

Sacramento, California, 95817, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20009, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20036, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33316, United States

Location

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

West Palm Beach, Florida, 33401, United States

Location

Unknown Facility

Atlanta, Georgia, 30312, United States

Location

Unknown Facility

Decatur, Georgia, 30033, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Berkley, Michigan, 48072, United States

Location

Unknown Facility

Newark, New Jersey, 07102, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Dallas, Texas, 75208, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Houston, Texas, 77098, United States

Location

Unknown Facility

Longview, Texas, 75605, United States

Location

Unknown Facility

Annandale, Virginia, 22003, United States

Location

Unknown Facility

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.

  PMID: 28219610 RESULT

• Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Wei X, Collins SE, Cheng A. Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide. AIDS. 2018 Jul 31;32(12):1723-1725. doi: 10.1097/QAD.0000000000001894.

  PMID: 29794828 RESULT

MeSH Terms

Interventions

imidazole mustard; bictegravir; dolutegravir

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: March 23, 2015
• Primary Completion: November 30, 2015
• Study Completion: February 27, 2019
• Last Updated: April 7, 2020
• Results First Posted: March 27, 2018

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)