Effects of BufferGel and PRO 2000/5 Gel in Men

• Status: Completed
• Trial end date: 1997-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

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.