Trials / Withdrawn
WithdrawnNCT06336434
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CAB LA 600mg | 600mg (3mL) IM Injection |
| DRUG | RPV LA 900mg | 900mg (3mL) IM Injection |
| DRUG | CAB LA 400mg | 400mg (2mL) IM Injection |
| DRUG | RPV LA 600mg | 600mg (2mL) IM injection |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2028-01-30
- Completion
- 2028-01-30
- First posted
- 2024-03-28
- Last updated
- 2025-07-31
Locations
8 sites across 2 countries: United States, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06336434. Inclusion in this directory is not an endorsement.