Bacterial DiseasesPhase 3NCT00170430
Reducing Vaginal Infections in Women
A Phase 3 study testing Fluconazole and Metronizadole in people with Bacterial Diseases and Other Mycoses, run by University of Washington at 1 site in Kenya.
Trial summary
The purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douching, bathing, and sexual practices can influence the risk of vaginal infections. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Diseases, Other Mycoses, Sexually Transmitted Infection
- What is being tested?
- Fluconazole and Metronizadole
- How many people
- 400 participants
- Where
- 1 siteKenya
- Study dates
- May 2003to Dec 2006
- Phase
- Phase 3
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who do not currently have symptoms of vaginal itching or discharge. Women with these symptoms may be treated and enrolled at a subsequent monthly visit when they are asymptomatic.
- Those who are currently menstruating may be enrolled after the completion of menses.
Who cannot join
- Pregnancy
- Lactation
- History of adverse reactions to the study medications
- Alcoholism or inability to abstain from alcohol for 48 hours following treatment
- Women who do not anticipate living in Mombasa for a year following enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Vaginal Infections in Women at Risk for HIV-1
The purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douching, bathing, and sexual practices can influence the risk of vaginal infections. Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16 and older, living in Mombasa. Study procedures will include sexual behavior questions, physical examinations including pelvic exams, testing of vaginal and cervical secretions for STDs, urine collection and blood samples. Participants will receive 2 different types of pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no medication). Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals.
Read the detailed description
Prospective studies in Africa have demonstrated that vaginal infections are associated with a significant increase in a woman's risk of infection with HIV-1. Further clinical and epidemiological research is needed to evaluate strategies for prevention and treatment of vaginal infections as a means of reducing HIV-1 acquisition. Developing a vaginal health intervention to reduce the risk of HIV-1 infection is a particularly important goal in sub-Saharan Africa, where female controlled strategies for reducing the risk of HIV-1 transmission may be an important means of decreasing the spread of the epidemic. This study will evaluate the efficacy of a regimen for reducing the rate of vaginal infections. The study is a double blind, randomized, controlled trial of monthly treatment with single-dose metronidazole and fluconazole as a means of decreasing vaginal infections and promoting normal vaginal flora in HIV-1 seronegative female sex workers (FSWs) in Mombasa, Kenya. Participants will be recruited from an existing cohort of HIV-1 seronegative FSWs followed at a municipal sexually transmitted disease (STD) clinic in Mombassa, Kenya, since February 1993. Participants will be randomized to treatment with metronidazole 2 grams plus fluconazole 150 mg once a month or placebo. All patients will be asked to return for follow-up after 1 month. All women in the study will be treated as indicated for symptomatic vaginal infections, other genital track infections and followed until they have completed 12 monthly follow-up visits.
- Being tested
- Fluconazole, Metronizadole
- Keywords
- HIV-1, sexually transmitted diseases, females, Kenya
- Medical subject headings
- Bacterial Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
MetronizadoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- R. Scott McClelland, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170430
- Sponsor's protocol ID
- 20486-A
- Other IDs
- 01-0777-A 01, 02-125
- Status last verified
- Mar 2010
- First submitted
- 9 Sep 2005
- Last updated
- 18 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Vaginal Infections in Women at Risk for HIV-1
- ClinicalTrials.gov ID
- NCT00170430
- Acronym / sponsor ID
- 20486-A
- Keywords
- HIV-1, sexually transmitted diseases, females, Kenya
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Sep 2005 (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 taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douching, bathing, and sexual practices can influence the risk of vaginal infections. Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16 and older, living in Mombasa. Study procedures will include sexual behavior questions, physical examinations including pelvic exams, testing of vaginal and cervical secretions for STDs, urine collection and blood samples. Participants will receive 2 different types of pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no medication). Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals.
Detailed description
Prospective studies in Africa have demonstrated that vaginal infections are associated with a significant increase in a woman's risk of infection with HIV-1. Further clinical and epidemiological research is needed to evaluate strategies for prevention and treatment of vaginal infections as a means of reducing HIV-1 acquisition. Developing a vaginal health intervention to reduce the risk of HIV-1 infection is a particularly important goal in sub-Saharan Africa, where female controlled strategies for reducing the risk of HIV-1 transmission may be an important means of decreasing the spread of the epidemic. This study will evaluate the efficacy of a regimen for reducing the rate of vaginal infections. The study is a double blind, randomized, controlled trial of monthly treatment with single-dose metronidazole and fluconazole as a means of decreasing vaginal infections and promoting normal vaginal flora in HIV-1 seronegative female sex workers (FSWs) in Mombasa, Kenya. Participants will be recruited from an existing cohort of HIV-1 seronegative FSWs followed at a municipal sexually transmitted disease (STD) clinic in Mombassa, Kenya, since February 1993. Participants will be randomized to treatment with metronidazole 2 grams plus fluconazole 150 mg once a month or placebo. All patients will be asked to return for follow-up after 1 month. All women in the study will be treated as indicated for symptomatic vaginal infections, other genital track infections and followed until they have completed 12 monthly follow-up visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women who do not currently have symptoms of vaginal itching or discharge. Women with these symptoms may be treated and enrolled at a subsequent monthly visit when they are asymptomatic.
- Those who are currently menstruating may be enrolled after the completion of menses.
Key exclusion criteria (5 listed)
- Pregnancy
- Lactation
- History of adverse reactions to the study medications
- Alcoholism or inability to abstain from alcohol for 48 hours following treatment
- Women who do not anticipate living in Mombasa for a year following enrollment.
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 |
|---|---|---|
| Fluconazole | Drug | – |
| Metronizadole | 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 18 Mar 2010.
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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.
R. Scott McClelland, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluconazole and Metronizadole in people with Bacterial Diseases and Other Mycoses, run by University of Washington at 1 site in Kenya.
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 2 inclusion and 5 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 18 Mar 2010. 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 Kenya. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Mar 2010.