HIV InfectionsPhase 1NCT00000927
A Study of BufferGel in Women
A Phase 1 study testing BufferGel 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 to use BufferGel in the vaginas of women who do not have HIV and who have a low risk of getting HIV. Many new cases of HIV are the result of heterosexual activity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- BufferGel
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants must have:
- HIV-negativity by licensed EIA.
- Willingness and ability to complete a study diary.
- A regular menstrual cycle with a minimum of 18 days between menses.
- Ability to insert BufferGel daily as required by the protocol.
- Cohort IA participants must:
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- Agree to abstain from sexual intercourse for the duration of the study.
- Cohort IB participants must:
- Agree to have vaginal intercourse at least 2 times per week and use non-lubricated condoms for each act of intercourse.
- Have currently (for 3 months or longer) a single sexual partner who is at low-risk for HIV infection.
Who cannot join
- Co-existing Condition:
- Participants with the following conditions or symptoms are excluded:
- A Grade 3 or higher liver, renal, or hematology abnormality.
- Menopausal.
- Breakthrough menstrual bleeding.
- Any STD or symptoms, as seen on pelvic exam, consistent with an STD or other genital tract infection or trauma including vaginitis, cervicitis, edema, erythema, ecchymosis, petechial hemorrhage, vulvar or cervicovaginal lesions or abrasions, subepithelial hemorrhage, or signs of genital tract infection (other than asymptomatic bacterial vaginosis) from laboratory evaluations.
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- Concurrent Medication:
- Excluded:
- Any vaginal product other than BufferGel, including lubricants and feminine hygiene products.
- Vaginal drying agents.
- Douche.
- Participation in any other microbicide or contraceptive study.
- Treatment for any STD.
- Participants with the following prior conditions are excluded:
- IUD, abnormal PAP smear, pregnancy, abortion, or gynecologic surgery in the last 3 months.
- Any of the following side effects related to Depo-provera use in the past 2 months:
- headaches, dizziness, abdominal pain, fatigue, or nervousness.
- Prior Medication:
- Excluded:
- A course of antibiotic therapy (other than treatment for malaria) in the last 14 days.
- Any spermicide within the past month.
- Initiation of Depo-provera for contraceptive purposes in the last 6 months.
- Risk Behavior:
- Excluded:
- Use of intravenous drugs currently or within the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
About this study
Official title: Phase I Vaginal Microbicide Study of BufferGel
The purpose of this study is to see if it is safe to use BufferGel in the vaginas of women who do not have HIV and who have a low risk of getting HIV.
Many new cases of HIV are the result of heterosexual activity. Condom use is currently the only effective way of preventing the spread of HIV and other sexually transmitted diseases (STDs). However, women, who have a greater risk of getting HIV, are often unable to convince their partner to use a condom. Therefore, it is important to develop methods that prevent the spread of HIV and that are controlled by the woman, such as medicines used in the vagina. BufferGel is known to kill the organisms that cause STDs, including HIV. BufferGel may do this without causing genital irritation and sores as other medicines do. More studies are needed to see if this is true.
Read the detailed description
Heterosexual transmission of HIV presently accounts for the vast majority of new HIV infections worldwide. Currently the condom is the only method available that has been shown to be effective against HIV and other sexually transmitted diseases (STDs). However, women who are at the greatest risk for acquiring HIV are often unable to negotiate condom use. Therefore, it is important that effective female-controlled barrier methods, such as topical microbicides, be made available to women. BufferGel has sufficient buffer capacity to acidify twice its own volume in human semen, which inactivates STD pathogens, including HIV. Unlike most other topical microbicides, BufferGel is non-detergent so it should not cause genital irritation and lesions. The safety and acceptability of BufferGel still need to be studied more carefully.
Participants are divided into two cohorts. Cohort IA consists of sexually abstinent women and cohort IB consists of sexually active women. Within each U.S. cohort, participants are assigned to apply BufferGel either once or twice daily. Within each international cohort, all participants apply BufferGel twice daily. Participants apply BufferGel for 14 days. Pelvic examinations are performed at Days 7 and 14.
- Conditions
- HIV Infections
- Being tested
- BufferGel
- Keywords
- Administration, Topical, Mucous Membrane, Anti-Infective Agents, Cervix Uteri, Vagina, Vulva, Buffers
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BufferGelDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenneth Mayer, Study chairKenrad Nelson, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000927
- Sponsor's protocol ID
- HIVNET 009
- Status last verified
- Mar 1999
- First submitted
- 2 Nov 1999
- Last updated
- 9 Jan 2007
- Results posted
- No
Publications
van De Wijgert J, Fullem A, Kelly C, Mehendale S, Rugpao S, Kumwenda N, Chirenje Z, Joshi S, Taha T, Padian N, Bollinger R, Nelson K. Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):21-7. doi: 10.1097/00126334-200101010-00003.
PubMed 11176265Mayer KH, Peipert J, Fleming T, Fullem A, Moench T, Cu-Uvin S, Bentley M, Chesney M, Rosenberg Z. Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States. Clin Infect Dis. 2001 Feb 1;32(3):476-82. doi: 10.1086/318496. Epub 2001 Jan 26.
PubMed 11170957
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Vaginal Microbicide Study of BufferGel
- ClinicalTrials.gov ID
- NCT00000927
- Acronym / sponsor ID
- HIVNET 009
- Conditions
- HIV Infections
- Keywords
- Administration, Topical, Mucous Membrane, Anti-Infective Agents, Cervix Uteri, Vagina, Vulva, Buffers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 to use BufferGel in the vaginas of women who do not have HIV and who have a low risk of getting HIV.
Many new cases of HIV are the result of heterosexual activity. Condom use is currently the only effective way of preventing the spread of HIV and other sexually transmitted diseases (STDs). However, women, who have a greater risk of getting HIV, are often unable to convince their partner to use a condom. Therefore, it is important to develop methods that prevent the spread of HIV and that are controlled by the woman, such as medicines used in the vagina. BufferGel is known to kill the organisms that cause STDs, including HIV. BufferGel may do this without causing genital irritation and sores as other medicines do. More studies are needed to see if this is true.
Detailed description
Heterosexual transmission of HIV presently accounts for the vast majority of new HIV infections worldwide. Currently the condom is the only method available that has been shown to be effective against HIV and other sexually transmitted diseases (STDs). However, women who are at the greatest risk for acquiring HIV are often unable to negotiate condom use. Therefore, it is important that effective female-controlled barrier methods, such as topical microbicides, be made available to women. BufferGel has sufficient buffer capacity to acidify twice its own volume in human semen, which inactivates STD pathogens, including HIV. Unlike most other topical microbicides, BufferGel is non-detergent so it should not cause genital irritation and lesions. The safety and acceptability of BufferGel still need to be studied more carefully.
Participants are divided into two cohorts. Cohort IA consists of sexually abstinent women and cohort IB consists of sexually active women. Within each U.S. cohort, participants are assigned to apply BufferGel either once or twice daily. Within each international cohort, all participants apply BufferGel twice daily. Participants apply BufferGel for 14 days. Pelvic examinations are performed at Days 7 and 14.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- HIV-negativity by licensed EIA.
- Willingness and ability to complete a study diary.
- A regular menstrual cycle with a minimum of 18 days between menses.
- Ability to insert BufferGel daily as required by the protocol.
- Agree to abstain from sexual intercourse for the duration of the study.
Key exclusion criteria (25 listed)
- A Grade 3 or higher liver, renal, or hematology abnormality.
- Menopausal.
- Breakthrough menstrual bleeding.
- Any STD or symptoms, as seen on pelvic exam, consistent with an STD or other genital tract infection or trauma including vaginitis, cervicitis, edema, erythema, ecchymosis, petechial hemorrhage, vulvar or cervicovaginal lesions or abrasions, subepithelial hemorrhage, or signs of genital tract infection (other than asymptomatic bacterial vaginosis) from laboratory evaluations.
- Any vaginal product other than BufferGel, including lubricants and feminine hygiene products.
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 |
|---|---|---|
| BufferGel | 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 9 Jan 2007.
- Background: PubMed 11176265van De Wijgert J, Fullem A, Kelly C, Mehendale S, Rugpao S, Kumwenda N, Chirenje Z, Joshi S, Taha T, Padian N, Bollinger R, Nelson K. Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):21-7. doi: 10.1097/00126334-200101010-00003.
- Background: PubMed 11170957Mayer KH, Peipert J, Fleming T, Fullem A, Moench T, Cu-Uvin S, Bentley M, Chesney M, Rosenberg Z. Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States. Clin Infect Dis. 2001 Feb 1;32(3):476-82. doi: 10.1086/318496. Epub 2001 Jan 26.
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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.
Kenneth Mayer study chair
Kenrad Nelson 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 BufferGel 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 10 inclusion and 25 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 9 Jan 2007. 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 NCT00000927, which also lists 2 linked publications.
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 9 Jan 2007.