CompletedPhase 1

Effects of BufferGel and PRO 2000/5 Gel in Men

United States24 participants

Plain-language summary

The purpose of this study is to find out if there are any bad effects when BufferGel or PRO 2000/5 Gel are applied to the penis of HIV-infected men. Microbicides are products to be used by women for placing into the vagina to prevent passing HIV from 1 person to another during sex. Studies have shown 2 investigational microbicides, BufferGel and PRO 2000/5 Gel, to be safe and acceptable for women and HIV-negative men. It is important to see if the side effects of these products are the same in men as those in women and to see if there is any difference in the side effects between circumcised and uncircumcised men.

Who can participate

Age range

18 Years

Sex

MALE

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 Patients may be eligible for this study if they: * Are male and at least 18 years old. * Are HIV-positive. * Have a CD4 cell count over 200 within the year before study entry. * Can speak and write English. * Can provide address, phone number, or other contact information. * Agree not to apply other products to the penis during the 3 weeks of product use. * Agree not to have sex, masturbate, or perform other activities that may irritate the penis during the 3 weeks of product use. Exclusion Criteria Patients will not be eligible for this study if they: * Are allergic to any ingredients in the study products. * Have had inflammation of the urethra (painful urination, burning, or itching) in the past. * Have had penis skin reactions, eczema, psoriasis, severe seborrheic dermatitis, or other similar problems in the past. * Have had a non-HIV sexually transmitted disease (STD), including a genital herpes outbreak, in the past 6 months. * Have had a change in anti-HIV drugs in the past 30 days. * Have taken part in any other study of an investigational product in the past 30 days. * Have broken skin on the penis. * Have signs or symptoms of an STD. * Apply topical products (e.g., creams or ointments) to the penis. * Have an abnormal finding on the physical or genital exam. * Have a positive result from a urine leukocyte esterase (LE) test. * Use any drugs that would affect the study, in the doctor's opinion.

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.

Trial details

NCT IDNCT00016536

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More HIV Infections trials