HIV InfectionsPhase 1NCT00000929
A Study of the Effects of Advantage 24 on the Rectum
A Phase 1 study testing Nonoxynol-9 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 see if it is safe and acceptable for homosexual male couples, where both partners have the same HIV status, to use Advantage 24 during anal intercourse. Advantage 24 is a spermicide (a chemical that kills sperm). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nonoxynol-9
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jul 1999
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Co-existing Condition:
- Participants with the following symptoms or conditions are excluded:
- Positive HSV-2 serology (HIV-negative participants only).
- Positive syphilis by Venereal Disease Research Laboratory (VDRL) serology and Fluorescent Treponemal Antibody (FTA) or Microhemagglutination Assay (MHA).
- Receptive partners with the following additional symptoms or conditions are excluded:
- Rectal gonorrhea or chlamydia by culture.
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- Active rectal inflammation, ulceration, or fissures.
- Insertive partners with the following additional symptoms or conditions are excluded:
- Penile or urethral irritation, rashes, or lesions.
- Penile or scrotal piercing.
- Concurrent Medication:
- Excluded for receptive partners:
- -
- Anticoagulant, including warfarin and heparin.
- Participants with the following prior conditions are excluded:
- Sensitivity or irritative symptoms when using N-9 or when exposed to latex.
- Three or more Herpes Simplex 2 Virus (HSV-2) outbreaks within 12 months prior to screening (HIV-positive participants only).
- One or more HSV-2 outbreaks within 6 months prior to screening (HIV-positive participants only).
- Receptive partners with the following additional prior conditions are excluded:
- Diagnosed inflammatory bowel disease, ulcerative colitis, Crohn's disease, or rectal malignancy.
- Diagnosed bleeding disorder, including hemophilia and thrombocytopenia.
- Rectal surgery including fistulectomy.
- Prosthetic heart valve or diagnosis of a valvular abnormality.
- Hemorrhoidectomy within 6 months prior to screening.
- Rectal burning, tenesmus, bleeding, or irritation in the week prior to screening.
- Diarrhea (more than 3 stools per day) in the week prior to screening.
- Use of rectally-inserted sex toys, practiced receptive fisting, or rectal douching in the week prior to screening.
- Insertive partners with the following additional prior conditions are excluded:
- Urethral burning or discharge in the week prior to screening.
- Prior Medication:
- Excluded for receptive partners:
- Use of laxatives in the week prior to screening.
- Participants meet the following criteria:
- HIV-negative or HIV-positive; participant's partner must be the same serostatus.
- Plan to have anal intercourse only with the study partner for the duration of the study. During all episodes in which Advantage 24 is used, one partner is exclusively insertive and the other partner is exclusively receptive.
- Sexual partner of at least 3 months is eligible and agrees to participate.
- Agree to use non-N-9 lubricant and condoms for all episodes of anal intercourse.
- Avoid use of Advantage 24 for purposes other than specified by the protocol.
- Receptive partners meet the following additional criteria:
- Plan to have receptive anal intercourse with the study partner with Advantage 24 applied rectally, and using N-9 lubricant and condoms, at the couple's usual frequency (at least 3 times per week).
- Agree to apply the specified amount of Advantage 24 daily to the rectum.
- Avoid use of laxatives, use of rectally-inserted sex toys, receptive fisting, and rectal douching.
- Insertive partners meet the following additional criteria:
- Plan to have insertive anal intercourse with the study partner with Advantage 24 applied to the glans of the penis, and using non-N-9 lubricant and condoms, at the couple's usual frequency (at least 3 times per week).
- Agree to apply the specified amount of Advantage 24 daily to the penis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Rectal Microbicide Study
The purpose of this study is to see if it is safe and acceptable for homosexual male couples, where both partners have the same HIV status, to use Advantage 24 during anal intercourse. Advantage 24 is a spermicide (a chemical that kills sperm).
Much research and development is being done with chemicals that can be controlled by the receptive partner to prevent the spread of HIV and other sexually transmitted diseases (STDs). Advantage 24 currently is used in the vagina as a form of birth control. The safety of Advantage 24 is particularly important for HIV-positive men because they have a greater chance of serious reaction to Advantage 24 due to other HIV-related conditions.
Read the detailed description
Chemical barriers which can be controlled by the receptive partner to prevent transmission of HIV and other sexually transmitted diseases (STDs) are among the highest priorities for research and development. Advantage 24 is a contraceptive gel containing nonoxynol-9 (N-9). This study provides information on the safety of N-9 in a bioadhesive gel formulated for use by MSM during anal intercourse. Safety is assessed for both HIV-positive and HIV-negative men because HIV-positive men may be at increased risk for toxicity due to other HIV-related conditions.
Participants are divided into 4 cohorts depending on their serostatus and whether they are the insertive or receptive partner. Participants apply Advantage 24 once or twice a day for 5 weeks and 4 times a day for the sixth week. Check-in visits, which include a genital exam, are performed at Weeks 1, 2, 4, 5, and 7. More complete physical evaluations, including anoscopy for receptive partners and blood tests, are performed at Weeks 3, 6, and 8.
- Conditions
- HIV Infections
- Being tested
- Nonoxynol-9
- Keywords
- Sexual Partners, Homosexuality, Male, Anti-Infective Agents, Patient Compliance, Nonoxynol, Rectum
- Medical subject headings
- HIV Infections, Homosexuality, Male, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonoxynol-9Drug
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 completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 70 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Connie Celum, Study chairSusan Buchbinder, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000929
- Sponsor's protocol ID
- HIVNET 008
- Other IDs
- 11715
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Rectal Microbicide Study
- ClinicalTrials.gov ID
- NCT00000929
- Acronym / sponsor ID
- HIVNET 008
- Conditions
- HIV Infections
- Keywords
- Sexual Partners, Homosexuality, Male, Anti-Infective Agents, Patient Compliance, Nonoxynol, Rectum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 1999 (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 see if it is safe and acceptable for homosexual male couples, where both partners have the same HIV status, to use Advantage 24 during anal intercourse. Advantage 24 is a spermicide (a chemical that kills sperm).
Much research and development is being done with chemicals that can be controlled by the receptive partner to prevent the spread of HIV and other sexually transmitted diseases (STDs). Advantage 24 currently is used in the vagina as a form of birth control. The safety of Advantage 24 is particularly important for HIV-positive men because they have a greater chance of serious reaction to Advantage 24 due to other HIV-related conditions.
Detailed description
Chemical barriers which can be controlled by the receptive partner to prevent transmission of HIV and other sexually transmitted diseases (STDs) are among the highest priorities for research and development. Advantage 24 is a contraceptive gel containing nonoxynol-9 (N-9). This study provides information on the safety of N-9 in a bioadhesive gel formulated for use by MSM during anal intercourse. Safety is assessed for both HIV-positive and HIV-negative men because HIV-positive men may be at increased risk for toxicity due to other HIV-related conditions.
Participants are divided into 4 cohorts depending on their serostatus and whether they are the insertive or receptive partner. Participants apply Advantage 24 once or twice a day for 5 weeks and 4 times a day for the sixth week. Check-in visits, which include a genital exam, are performed at Weeks 1, 2, 4, 5, and 7. More complete physical evaluations, including anoscopy for receptive partners and blood tests, are performed at Weeks 3, 6, and 8.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (45 listed)
- Positive HSV-2 serology (HIV-negative participants only).
- Positive syphilis by Venereal Disease Research Laboratory (VDRL) serology and Fluorescent Treponemal Antibody (FTA) or Microhemagglutination Assay (MHA).
- Rectal gonorrhea or chlamydia by culture.
- Active rectal inflammation, ulceration, or fissures.
- Penile or urethral irritation, rashes, or lesions.
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 |
|---|---|---|
| Nonoxynol-9 | 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 29 Oct 2021.
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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
Susan Buchbinder 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 Nonoxynol-9 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 0 inclusion and 45 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 29 Oct 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?
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 29 Oct 2021.