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A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States - NCT00799058-35294(Clinical Trial 255791)



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City:  Birmingham
State:  
AL
Zip Code: 35294
Conditions: HIV-1 Infections
Purpose: IPM 020 is a double-blind, randomized, placebo-controlled Phase I/II expanded safety trial being conducted at 5 research centers in the United States among approximately 180 healthy, sexually active, HIV-negative women to assess the safety of Dapivirine Gel 4759, 0.05% 2.5g and Dapivirine Gel 4789, 0.05% 2.5g as compared to the HEC-based universal placebo.
Study summary:
Criteria: Inclusion Criteria: 1. Women 18 to 40 years of age inclusive who can give written informed consent 2. Available for all visits and consent to follow all procedures scheduled for the trial 3. Healthy and self-reported sexually active 4. HIV-negative as determined by an HIV test at time of enrollment 5. Willing to be on a stable form of contraception 6. In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle 7. Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff 8. Asymptomatic for genital infections at the time of enrollment 9. Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial. 10. Documentation of no abnormality on Pap smear within 90 days prior to randomization; 11. Willing to answer acceptability and adherence questionnaires throughout the trial 12. Willing to refrain from participation in any other research trial for the duration of this trial 13. Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures 14. Willing to abstain from all the following criteria beginning 48 hours prior to each trial visit: - Vaginal intercourse - Oral contact with her genitalia - Internal vaginal washing - Penetration of the vagina by fingers, sex toys, or any other objects, including medications 15. Willing to abstain from all of the following for 3 days after biopsy procedures: - Vaginal intercourse - Oral contact with her genitalia - Internal vaginal washing - Penetration of the vagina by fingers, sex toys, or any other objects, including medications Exclusion Criteria: 1. Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening 2. Currently breast-feeding, or having breastfed within 3 months prior to screening 3. Receipt of any investigational agent within 60 days prior to screening 4. Previously participated in any HIV vaccine trial 5. Untreated urogenital infections within 2 weeks prior to enrollment 6. Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy 7. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction 8. Pap smear result at screening that requires cryotherapy, biopsy or treatment (other than for infection) 9. History of symptomatic or asymptomatic HSV-2 10. Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline 11. Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal intercourse; or urogenital surgery within 90 days prior to enrollment 12. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex 13. Any serious acute, chronic or progressive disease 14. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
Study is available at: University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)
Birmingham, AL 35294
United States
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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