Clinical trial NCT02275065: Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
Official title: A Phase 1b Randomized, Double-Blinded, Sequential Cohort Placebo-Controlled Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1 Infection
Keywords: HIV-1 Infected
Adults
Treatment Naive
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA
timeFrame: Baseline up to Day 11
Secondary outcomes:
measure: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)
timeFrame: First dose date up to last dose date plus 30 days (Maximum: 40 days)
measure: Percentage of Participants Who Experienced Graded Laboratory Abnormalities
timeFrame: First dose date up to last dose date plus 30 days (Maximum: 40 days)
measure: Maximum Reduction From Baseline Through Day 17 in Plasma HIV-1 RNA
timeFrame: Baseline to Day 17
measure: Viral Decay Slope in Plasma HIV-1 RNA
timeFrame: Baseline up to Day 11
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL
timeFrame: Day 17
measure: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir Following Single-Dose and Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 for single dose and Day 10 for multiple dose
measure: PK Parameter: Tmax of Bictegravir Following Single-Dose and Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 for single dose and Day 10 for multiple dose
measure: PK Parameter: AUC0-24 of Bictegravir Following Single-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1
measure: PK Parameter: AUClast of Bictegravir Following Single-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1
measure: PK Parameter: AUCtau of Bictegravir Following Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
measure: PK Parameter: t1/2 of Bictegravir Following Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
measure: PK Parameter: Ctau of Bictegravir Following Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
measure: PK Parameter: CLss/F of Bictegravir Following Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
measure: PK Parameter: AR_AUC of Bictegravir Following Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10
measure: PK Parameter: AR_Cmax of Bictegravir Following Multiple-Dose Administration
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10
measure: PK/Pharmacodynamic (PD) Analysis: Pearson Correlation Between AUCtau of Bictegravir and DAVG11 in Plasma HIV-1 RNA
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
Other outcomes:
Locations:
city: Berkeley
country: United States
state: California
city: Davis
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Fort Lauderdale
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Berkley
country: United States
state: Michigan
city: Newark
country: United States
state: New Jersey
city: Santa Fe
country: United States
state: New Mexico
city: Dallas
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: