Phase 1
Completed N=23
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
Source: ClinicalTrials.gov NCT02275065 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA — 4.26; 4.64; 4.42; 4.71 log10 copies/mL — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA |
4.26; 4.64; 4.42; 4.71; 4.50; -0.92 | <0.001 sig |
| SECONDARY Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) |
75.0; 25.0; 50.0; 50.0; 25.0 | — |
| SECONDARY Percentage of Participants Who Experienced Graded Laboratory Abnormalities |
75.0; 25.0; 0; 25.0; 50.0 | — |
| SECONDARY Maximum Reduction From Baseline Through Day 17 in Plasma HIV-1 RNA |
-1.52; -2.18; -2.31; -2.91; -0.12 | <0.001 sig |
| SECONDARY Viral Decay Slope in Plasma HIV-1 RNA |
-0.184; -0.252; -0.272; -0.315; -0.011 | <0.001 sig |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL |
0; 0; 25.0; 50.0; 0 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Cmax of Bictegravir Following Single-Dose and Multiple-Dose Administration |
493.3; 2565.0; 4957.5; 7367.5; 741.5; 3475.0 | — |
| SECONDARY PK Parameter: Tmax of Bictegravir Following Single-Dose and Multiple-Dose Administration |
1.00; 1.83; 1.75; 1.50; 1.50; 1.25 | — |
| SECONDARY PK Parameter: AUC0-24 of Bictegravir Following Single-Dose Administration |
6262.2; 31291.8; 68476.5; 94588.5 | — |
| SECONDARY PK Parameter: AUClast of Bictegravir Following Single-Dose Administration |
6295.5; 31401.0; 68485.6; 94827.0 | — |
| SECONDARY PK Parameter: AUCtau of Bictegravir Following Multiple-Dose Administration |
9983.0; 48950.3; 87538.4; 178901.7 | — |
| SECONDARY PK Parameter: t1/2 of Bictegravir Following Multiple-Dose Administration |
20.79; 15.86; 17.84; 20.88 | — |
| SECONDARY PK Parameter: Ctau of Bictegravir Following Multiple-Dose Administration |
225.3; 1052.3; 2053.0; 4520.0 | — |
| SECONDARY PK Parameter: CLss/F of Bictegravir Following Multiple-Dose Administration |
523.8; 567.3; 621.9; 570.6 | — |
| SECONDARY PK Parameter: AR_AUC of Bictegravir Following Multiple-Dose Administration |
160.2; 157.4; 125.3; 193.3 | — |
| SECONDARY PK Parameter: AR_Cmax of Bictegravir Following Multiple-Dose Administration |
149.8; 138.5; 122.0; 168.4 | — |
| SECONDARY PK/Pharmacodynamic (PD) Analysis: Pearson Correlation Between AUCtau of Bictegravir and DAVG11 in Plasma HIV-1 RNA |
-1.000; 0.275; -0.940; 0.713 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02275065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.