Trials / Completed
CompletedNCT04143594
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV
A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 183 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral Lenacapavir | Tablets administered without regard to food |
| DRUG | F/TAF | Tablets administered without regard to food |
| DRUG | Subcutaneous Lenacapavir | Administered in the abdomen via subcutaneous injections |
| DRUG | TAF | Tablets administered without regard to food |
| DRUG | BIC | Tablets administered without regard to food |
| DRUG | B/F/TAF | Tablets administered without regard to food |
Timeline
- Start date
- 2019-11-22
- Primary completion
- 2021-10-05
- Completion
- 2023-09-19
- First posted
- 2019-10-29
- Last updated
- 2024-10-02
- Results posted
- 2022-12-19
Locations
53 sites across 3 countries: United States, Dominican Republic, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04143594. Inclusion in this directory is not an endorsement.