HIV-1 Infection
Conditions
Brief summary
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH). The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start. The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.
Interventions
DRUGB/F/TAF
Tablet administered orally
DRUGGS-3242
Tablet administered orally
DRUGLenacapavir
Tablet administered orally
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up. * Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception. * Negative serum pregnancy test at screening and negative urine test at enrollment. * Receiving B/F/TAF for ≥ 6 months prior to screening. * Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 6 months before and at screening. * No resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S) on available historical resistance reports. * CD4 ≥ 200 cells/mm\^3 at screening Key
Exclusion criteria
* Plans to breastfeed during the study period and 60 days following the last dose of study intervention. * History of virologic failure while on an integrase strand-transfer inhibitor-based regimen. * Creatinine clearance according to the Cockcroft-Gault formula \< 60 mL/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm | Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm | Week 12 | — |
| Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm | Week 48 | — |
| Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm | Week 12 | — |
| Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm | Week 24 | — |
| Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm | Week 48 | — |
| Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12 | Week 12 | — |
| Change From Baseline in CD4 Cell Count at Week 24 | Week 24 | — |
| Change From Baseline in CD4 Cell Count at Week 48 | Week 48 | — |
| The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12 | Week 12 | — |
| The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24 | Week 24 | — |
| The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48 | Week 48 | — |
| Pharmacokinetic (PK) Parameter: Cmax of GS-3242 | Up to 48 weeks | Cmax is defined as the maximum observed concentration of drug. |
| PK Parameter: Tmax of GS-3242 | Up to 48 weeks | Tmax is defined as the time (observed time point) of Cmax. |
| PK Parameter: Ctau of GS-3242 | Up to 48 weeks | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
| PK Parameter: AUCtau of GS-3242 | Up to 48 weeks | AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Countries
United States
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed