CompletedPhase 1

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

United States13 participantsStarted 2018-06-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women (cis or transgender) who are 18 years or older at Screening, verified per site standard operating procedure (SOP) * Able and willing to provide written informed consent * HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in the protocol and willing to receive HIV test results * Able and willing to provide adequate locator information, as defined in site SOP * Available to return for all study visits and willing to comply with study participation requirements * In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee * At Screening, history of consensual receptive anal intercourse (RAI) at least once in their lifetime per participant report * Willing to not take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation (including the time between Screening and Enrollment) * Willing to follow abstinence requirements for the duration of study participation (See the protocol for additional information) * For participants of childbearing potential: a negative pregnancy test at Screening and Enrollment * For participants of childbearing potential: Per participant report at Enrollment, using an effective method of contraception and intending to use an effective method for the duration of study participation; these include: * Hormonal methods, excluding vaginal rings * Intr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of Grade 2 or Higher Adverse Events (AEs)

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

MIV-150 Concentrations in Plasma

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

MIV-150 Concentrations in Rectal Fluid

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Trial details

NCT IDNCT03408899

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-04-19

Results submitted2022-12-12

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Frequency of Grade 2 or Higher Adverse Events (AEs)

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

MIV-150 Concentrations in Plasma

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

MIV-150 Concentrations in Rectal Fluid

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant