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

NCT ID: NCT02275065

Last Updated: 2020-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-24

Study Completion Date

2015-01-29

Brief Summary

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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.

Detailed Description

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Conditions

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HIV-1 Infection

Keywords

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HIV-1 Infected Adults Treatment Naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bictegravir 5 mg

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

Group Type EXPERIMENTAL

Bictegravir

Intervention Type DRUG

Bictegravir tablet(s) administered orally once daily

Bictegravir 25 mg

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

Group Type EXPERIMENTAL

Bictegravir

Intervention Type DRUG

Bictegravir tablet(s) administered orally once daily

Bictegravir 50 mg

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

Group Type EXPERIMENTAL

Bictegravir

Intervention Type DRUG

Bictegravir tablet(s) administered orally once daily

Bictegravir 100 mg

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

Group Type EXPERIMENTAL

Bictegravir

Intervention Type DRUG

Bictegravir tablet(s) administered orally once daily

Placebo

Placebo matched to bictegravir tablet for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match bictegravir administered orally once daily

Interventions

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Bictegravir

Bictegravir tablet(s) administered orally once daily

Intervention Type DRUG

Placebo

Placebo to match bictegravir administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Berkeley, California, United States

Site Status

Davis, California, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

San Francisco, California, United States

Site Status

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

Site Status

Fort Lauderdale, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Vero Beach, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Berkley, Michigan, United States

Site Status

Newark, New Jersey, United States

Site Status

Santa Fe, New Mexico, United States

Site Status

Dallas, Texas, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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GS-US-141-1219

Identifier Type: -

Identifier Source: org_study_id