Effects of BufferGel and PRO 2000/5 Gel in Men
Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
May 1, 1997
CompletedFirst Submitted
Initial submission to the registry
May 16, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
May 16, 2001
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UW HIV Prevention CRS
Seattle, Washington, 98104, United States
Related Publications (1)
Tabet SR, Callahan MM, Mauck CK, Gai F, Coletti AS, Profy AT, Moench TR, Soto-Torres LE, Poindexter III AN, Frezieres RG, Walsh TL, Kelly CW, Richardson BA, Van Damme L, Celum CL. Safety and acceptability of penile application of 2 candidate topical microbicides: BufferGel and PRO 2000 Gel: 3 randomized trials in healthy low-risk men and HIV-positive men. J Acquir Immune Defic Syndr. 2003 Aug 1;33(4):476-83. doi: 10.1097/00126334-200308010-00008.
PMID: 12869836RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Connie Celum
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2001
First Posted
August 31, 2001
Study Completion
May 1, 1997
Last Updated
November 1, 2021
Record last verified: 2021-10