| Protocol No: | ECCT/11/04/01 | Date of Protocol: | 29-07-2010 |
| Study Title: |
A Double-blind, Randomized Trial of Monthly Treatment with Metronidazole and Miconazole Co-formulated Suppositories versus Placebo for Preventing Vaginal Infections in HIVSeronegative Women (DMID Protocol Number: 09-0070)
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| Study Objectives: | |
| Laymans Summary: | |
| Abstract of Study: |
PROTOCOL SUMMARY
Phase: II
Population: 234 women who are sexually active (>4 episodes of heterosexual intercourse during the past month), HIV-seronegative, 18 to 45 years old, with bacterial vaginosis (BV) and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis detected by laboratory testing at a screening visit
Number of Sites: Four (3 in Kenya and 1 in the U.S.)
Study Duration: 24 months for accrual and follow-up
Subject Participation Duration: 12 months total (Enrollment to End of Study Evaluation)
Description of Agent or Intervention: Intravaginal metronidazole 750 mg plus miconazole 200 mg (coformulated suppositories) versus matching placebo
suppositories nightly for five consecutive nights each month
Indication: Treatment for bacterial vaginosis and/or vulvovaginal candidiasis and/or Trichomonas vaginalis infection and/or mixed infections with two or more of these conditions
Objectives:
Primary - To evaluate the effect of monthly periodic presumptive treatment (PPT) using topical metronidazole 750 mg with miconazole 200 mg intravaginal suppositories versus matching placebo nightly for five nights each month for reducing the rates of BV by Gram stain (Nugent’s criteria) and VVC (detection on vaginal saline/KOH wet mount plus positive culture on Sabouraud’s agar) in a randomized, double-blind, placebocontrolled trial in sexually active, HIV-seronegative women. The two primary endpoints, BV and VVC, will be analyzed separately.
Secondary - To evaluate the effect of monthly PPT using topical metronidazole 750 mg with miconazole 200 mg intravaginal suppositories versus matching placebo nightly for five nights each month for reducing the overall rate of vaginal infections (combined endpoint including BV by Gram stain [Nugent’s criteria], VVC [vaginal saline/KOH wet mount plus positive culture on Sabouraud’s agar] and Trichomonas vaginalis infection [nucleic acid amplification based detection]) in a randomized, double-blind, placebo-controlled trial in sexually active, HIV-seronegative women. To evaluate the effect of monthly PPT using topical metronidazole 750 mg with miconazole 200 mg intravaginal suppositories versus matching placebo nightly for five nights each month for reducing the rate of BV by clinical criteria (Amsel’s criteria) in a randomized, double-blind, placebocontrolled trial in sexually active, HIV-seronegative women.
Description of Study Design:
The proposed study is a randomized, double-blind, placebocontrolled, two arm clinical trial (N=117 in each arm).
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