Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03408899
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2018-01-18
Brief Title:
Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase 1 Safety and Pharmacokinetic Study of PC-1005 MIV-150Zinc AcetateCarrageenan Gel Administered Rectally to HIV-1 Seronegative Adults
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 study is to evaluate the safety and pharmacokinetics of PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women cis or transgender with a history of consensual receptive anal intercourse
Detailed Description:
PC-1005 is a multipurpose prevention technology MPT microbicide in development that is active against HIV HPV and HSV-2 This study will evaluate the safety and pharmacokinetics of PC-1005 gel when administered rectally
The study will enroll HIV-uninfected men and women cis or transgender with a history of consensual receptive anal intercourse All participants will receive 3 single escalating doses of rectally administered PC-1005 4 mL 16 mL and 32 mL
The study includes a total of 9 clinic visits and 1 follow-up contact by phone or in person Participants will receive doses of PC-1005 at Visits 3 5 and 7 A 2-to-6 week washout period will follow each dosing visit If no adverse events that preclude continuation to the next dose are identified during this period participants will receive the next scheduled dose of PC-1005 Participation in this study will last approximately 3 to 5 months
Study visits will include physical examinations throat swabs behavioral assessments and interviews and collection of blood urine rectal tissue and cervical vaginal and rectal fluid
The study will enroll HIV-uninfected men and women cis or transgender with a history of consensual receptive anal intercourse All participants will receive 3 single escalating doses of rectally administered PC-1005 4 mL 16 mL and 32 mL
The study includes a total of 9 clinic visits and 1 follow-up contact by phone or in person Participants will receive doses of PC-1005 at Visits 3 5 and 7 A 2-to-6 week washout period will follow each dosing visit If no adverse events that preclude continuation to the next dose are identified during this period participants will receive the next scheduled dose of PC-1005 Participation in this study will last approximately 3 to 5 months
Study visits will include physical examinations throat swabs behavioral assessments and interviews and collection of blood urine rectal tissue and cervical vaginal and rectal fluid
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 35122 | REGISTRY | DAIDS-ES Registry Number | None |