NCT03408899

Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults

A Phase 1 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	PC-1005 gel	PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL, 16 mL, and 32 mL doses administered rectally.

Timeline

• Start date: 2018-06-19
• Primary completion: 2019-04-19
• Completion: 2019-04-19
• First posted: 2018-01-24
• Last updated: 2023-04-14
• Results posted: 2023-04-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study