Clinical trial
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir…
NCT03164564 · National Institute of Allergy and Infectious Diseases (NIAID), NIH · Active, not recruiting
Key facts
| NCT number | NCT03164564 |
|---|---|
| Title | Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women |
| Official title | A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID), NIH |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | HIV Infections |
| Intervention type | Drug |
| Interventions | Oral CAB, Oral TDF/FTC, Placebo for oral CAB, Placebo for oral TDF/FTC, CAB LA, Placebo for CAB LA |
| Enrollment | 3,224 |
| Start date | Nov 7, 2017 |
| Primary completion | Nov 5, 2020 |
| Completion | Oct 17, 2026 |
| First posted | May 23, 2017 |
| Last update posted | Oct 9, 2025 |
| Countries | Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, Zimbabwe |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: