Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05156658
Status:
WITHDRAWN
Last Update Posted:
2024-12-13
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Interactions of ENG Subdermal Implants with Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA)
Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Organization:
Study Overview
Official Title:
Pharmacokinetic Interactions of Etonogestrel (ENG) Subdermal Implants with Long-Acting (LA) Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA) in Participants of Reproductive Potential
Status:
WITHDRAWN
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol's question was answered elsewhere and very low site interest in the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this pharmacokinetic (PK) trial is to evaluate whether the ENG implant, a long-acting birth control method, is tolerable and effective for adults with HIV who are taking long-acting cabotegravir (CAB-LA) and long-acting rilpivirine (RPV-LA). Access to safe and effective birth control for adults with HIV is important because it may result in fewer infants exposed to HIV in the womb or born with HIV. Researchers believe that people of childbearing potential need access to birth control options that do not need to be negotiated with a partner.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UM1AI068636 | NIH | None | https://reporter.nih.gov/quic… | View |