HIV InfectionsPhase 1NCT00016536
Effects of BufferGel and PRO 2000/5 Gel in Men
A Phase 1 study testing Naphthalene 2-sulfonate polymer and Carbopol polymer in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Naphthalene 2-sulfonate polymer and Carbopol polymer
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento May 1997
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Naphthalene 2-sulfonate polymer, Carbopol polymer
- Keywords
- Antiviral Agents, Mucous Membrane, Spermatocidal Agents, Penis, Epithelium, PRO 2000, Urethra, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naphthalene 2-sulfonate polymerDrug
Carbopol polymerDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionMay 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Intervention model
- Crossover
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Connie Celum, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016536
- Sponsor's protocol ID
- HPTN 032
- Other IDs
- 10693
- Status last verified
- Oct 2021
- First submitted
- 16 May 2001
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
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.
PubMed 12869836
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)
- ClinicalTrials.gov ID
- NCT00016536
- Acronym / sponsor ID
- HPTN 032
- Conditions
- HIV Infections
- Keywords
- Antiviral Agents, Mucous Membrane, Spermatocidal Agents, Penis, Epithelium, PRO 2000, Urethra, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 1997 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Intervention model
- Crossover
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naphthalene 2-sulfonate polymer | Drug | – |
| Carbopol polymer | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Results publication: PubMed 12869836Tabet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Celum study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naphthalene 2-sulfonate polymer and Carbopol polymer in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00016536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.