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Also known as GS-3242 Tablet
GS-3242 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phase 2: Part A: Group 1 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN for at least 52 weeks. |
| Phase 2: Part A: Group 2 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks. |
| Phase 2: Part A: Group 3 of B/F/TAF | EXPERIMENTAL | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks. |
| Phase 2: Part B: Group 4 of GS-3242 + LEN | EXPERIMENTAL | Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks. |
| Phase 3: Group 1 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks. |
| Phase 3: Group 2 of B/F/TAF | EXPERIMENTAL | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks. |
| Part A: Group 1 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks. |
| Part A: Group 2 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks. |
| Part A: Group 3 of B/F/TAF | EXPERIMENTAL | Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks. |
| Part B: Group 4 (Conditional) of GS-3242 + LEN | EXPERIMENTAL | Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks. |
| Cohort 1: Single Dose of GS-3242 | EXPERIMENTAL | Participants in cohort 1 will receive single dose of GS-3242 450 mg on Days 1 and 2 in the fasted condition. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®) (BVY), or an alternative standard of care (SOC) antiretroviral (ART) regimen (example INSTI + NRTIs: dolutegravir (DTG)/abacavir (ABC)/3TC or DTG/3TC) up to Day 39. Following the completion of Cohort 1, additional cohorts may be opened for enrollment if further data are needed. Doses of GS-3242 will be based on safety and pharmacokinetic (PK) data from ongoing Phase 1a studies. |
| Name | Type | Description |
|---|---|---|
| GS-3242 Tablet | DRUG | Administered orally |
| GS-3242 Injection | DRUG | Administered intramuscularly (IM) |
| Lenacapavir Tablet | DRUG | Administered orally |
| Lenacapavir Injection | DRUG | Administered IM |
| B/F/TAF | DRUG | Administered orally |
| GS-3242 | DRUG | Administered orally |
| BVY | DRUG | Administered orally |
| Standard of Care | DRUG | Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC) |
Key Inclusion Criteria: * HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening. * Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening. Key Exclusion Criteria: * Prior usage...
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GS-3242 is an investigational small molecule being developed for the treatment of HIV-1 infection. It is currently in Phase 2 clinical trials, where it is being studied in combination with other antiretroviral agents for both virologically suppressed and treatment-naive people living with HIV-1.
GS-3242 targets integrase, a viral protein essential for HIV-1 replication. By inhibiting integrase, GS-3242 is designed to block the integration of viral DNA into the host cell genome, a critical step in the HIV-1 life cycle.
GS-3242 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting multiple clinical trials to evaluate the safety and efficacy of GS-3242 in people with HIV-1 infection.
GS-3242 is in Phase 2 clinical development. It has completed one Phase 1 study and is currently being evaluated in two Phase 2 trials, both of which are recruiting participants. GS-3242 is not yet approved and remains an investigational agent.
GS-3242 is being studied in three clinical trials. NCT07001319 is a completed Phase 1 study. NCT07645287 is a Phase 2 trial combining GS-3242 with lenacapavir versus Biktarvy in virologically suppressed people. NCT07708727 is a Phase 2 trial of an injectable GS-3242 and lenacapavir regimen in treatment-naive individuals.
Yes, GS-3242 Tablet is another name for GS-3242. The tablet formulation is the oral dosage form of this investigational integrase inhibitor being developed by Gilead Sciences for the treatment of HIV-1 infection.