Status:
COMPLETED
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Vaginosis
Candidiasis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come bac...
Detailed Description
Vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas (T.) vaginalis are common and have been associated with increased risk of HIV and other sexually ...
Eligibility Criteria
Inclusion
- Informed consent obtained and informed consent form (ICF) signed.
- Female, aged 18-45 years.
- Sexually active with greater than or equal to 4 episodes of sex with a male partner during the past month.
- Human immunodeficiency virus (HIV)-seronegative on both HIV tests in parallel screening.
- Presence of bacterial vaginosis (BV) and/or vulvovaginal candidiasis (VVC) and/or T. vaginalis infection at screening:
- BV: Microscopic criteria (Nugent's score greater than or equal to 7)
- VVC: Fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar.
- T. vaginalis infection: Identification of motile trichomonads on vaginal saline wet preparation.
- Able and willing to comply with study visit schedule and procedures during the 12-month period of follow-up.
- Able and willing to abstain from sex or to use non-latex condoms (provided) for 24 hours following insertion of each vaginal suppository.
- Willing to abstain from alcohol during, and for 48 hours after, treatment.
- Plan to remain in study area for the next year.
- Agree to not participate in other research studies involving drugs, medical devices, or vaginal products for the duration of study.
Exclusion
- Currently pregnant (positive urine Beta-Human Chorionic Gonadotropin (hCG) or planning to conceive during the next 12 months (by self-report).
- Currently breastfeeding.
- Within first 3 months post-partum.
- Current menstruation - women who are currently menstruating may be enrolled following the completion of menses.
- History of 4 or more episodes of treatment for any vaginal infection in the past 12 months. This would be a cumulative total, including any treatment for bacterial vaginosis (BV) and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis (TV) and/or syndromic.
- History of medical condition that would contraindicate use of the study product
- Porphyria
- Epilepsy
- Serious liver disease or signs and symptoms consistent with serious liver disease including jaundice, ascites, esophageal varices, encephalopathy, and bleeding disorders.
- Renal failure
- History of adverse reaction to the study medications (intravaginal metronidazole or miconazole).
- Current use of medication that may interact with the study drug (due to vaginal absorption of study drug)
- Warfarin
- Phenytoin
- Phenobarbital
- Disulfiram
- Cimetidine
- Lithium
- Astemizole
- Terfenadine
- Current use of oral or intravaginal antifungal medication.
- Current use of oral or intravaginal metronidazole, tinidazole, or clindamycin.
- Current use of latex diaphragm.
- As determined by the investigator, a medical condition or situation exists such that study participation would not be advisable.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT01230814
Start Date
April 1 2011
End Date
August 1 2013
Last Update
October 6 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35294-0007
2
Women's Health Project - Ganjoni Municipal Clinic
Mombasa, Coast, Kenya
3
University of Nairobi - Center for STD/HIV Research & Training
Nairobi, Nairobi County, Kenya
4
University of Nairobi - Kenya AIDS Vaccine Initiative
Nairobi, Nairobi County, Kenya