Effects of BufferGel and PRO 2000/5 Gel in Men
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
First received: May 16, 2001
Last updated: April 3, 2012
Last Verified: April 2012
History of Changes
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.
Drug : Naphthalene 2-sulfonate polymer
Drug : Carbopol polymer
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)|
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
|Study Completion Date:||May 1997|
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
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.
- 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.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016536
Locations Show More
|United States, Washington|
|UW HIV Prevention CRS|
|Seattle, Washington, United States, 98104|
Sponsors and CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
|Study Chair:||Connie Celum|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00016536 History of Changes|
|Other Study ID Numbers:||HPTN 032|
|Study First Received:||May 16, 2001|
|Last Updated:||April 3, 2012|
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):Antiviral Agents
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.