Effects of BufferGel and PRO 2000/5 Gel in Men

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Topical microbicides are products designed to prevent the sexual transmission of HIV and other disease pathogens. Studies have shown that nonoxynol-9, a detergent microbicide, can cause mucosal erosion and ulceration and increased risk of HIV infection. Attention has been given to developing non-detergent topical microbicides, such as BufferGel and PRO 2000/5 Gel. Studies have shown these products to be safe and acceptable for vaginal use [AS PER AMENDMENT 08/20/01: "however, none of the clinical studies to date have investigated the effects on the penile epithelium and urethral mucosa" has been replaced with: Phase I trials also have been conducted to assess the safety of BufferGel and PRO 2000/5 Gel (P) on the penile epithelium and urethral mucosa. In 1 trial, HIV-uninfected men applied either PRO 2000/5 or a gel containing the inactive ingredients of PRO 2000/5 for 7 days. A few patients reported mild symptoms of genital itching, tingling, irritation, dryness, discoloration, or flaking of the dried gel. In a similar trial comparing BufferGel and K-Y Jelly, a few patients reported similar symptoms.] It is important to determine whether the frequency and severity of adverse events experienced by men is comparable to that observed among women. It is also important to determine whether these adverse events are similar between circumcised and uncircumcised men.

Patients are assigned randomly to 1 of 6 possible sequences of product use. Patients complete 3 weeks of nightly product application (7 consecutive nights each of BufferGel, PRO 2000/5 Gel, and placebo gel) separated by a one-week washout between product-use periods. Patients apply the gel to the shaft and glans of the penis at bedtime, leave on for a minimum of 6 hours, and wash off the next morning. Patients maintain a diary of product application and removal, side effects, and use of other medications. Follow-up evaluations, including a genital exam and urine testing, are performed after each product-use and washout period. [AS PER AMENDMENT 08/20/01: Digital photographs will be taken of any observed abnormality or normal area that is needed for clinical decision making and/or documentation purposes.] In addition, adherence is assessed, the patient diary is reviewed, and product acceptability questionnaires are administered after each product-use period. Patients receive monetary compensation for participation.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • UW HIV Prevention CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Interventional Model: Crossover Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Connie Celum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

May 1, 1997

Study Registration Dates

First Submitted

May 16, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPTN 032
  • 10693 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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