Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HIV-1 Infection

Treatments: Drug: Bictegravir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275065

GS-US-141-1219

Details and patient eligibility

About

The primary objective of the study is to investigate the short-term antiviral potency of bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
• Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
• Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

• Anticipated to start HIV-1 therapy during the study period
• Active participation in another study of investigational or approved ART agents
• A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
• Participants with positive hepatitis C antibody at screening
• Chronic hepatitis B virus (HBV) infection
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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23 participants in 5 patient groups, including a placebo group

Bictegravir 5 mg

Experimental group

Description:

Bictegravir 5 mg (1 × 5 mg tablet) for 10 days

Treatment:

Drug: Bictegravir

Bictegravir 25 mg

Experimental group

Description:

Bictegravir 25 mg (1 × 25 mg tablet) for 10 days

Treatment:

Drug: Bictegravir

Bictegravir 50 mg

Experimental group

Description:

Bictegravir 50 mg (2 × 25 mg tablets) for 10 days

Treatment:

Drug: Bictegravir

Bictegravir 100 mg

Experimental group

Description:

Bictegravir 100 mg (1 × 100 mg tablet) for 10 days

Treatment:

Drug: Bictegravir

Placebo

Placebo Comparator group

Description:

Placebo matched to bictegravir tablet for 10 days

Treatment:

Drug: Placebo