Status:
COMPLETED
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
Lead Sponsor:
International Partnership for Microbicides, Inc.
Conditions:
HIV-1 Infections
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal ...
Detailed Description
This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acc...
Eligibility Criteria
Inclusion
- Women 18 to 40 years of age inclusive who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Healthy and self-reported sexually active
- HIV-negative as determined by an HIV test at time of enrollment
- Willing to be on a stable form of contraception
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle
- Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff
- Asymptomatic for genital infections at the time of enrollment
- Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial.
- Documentation of no abnormality on Pap smear within 90 days prior to randomization;
- Willing to answer acceptability and adherence questionnaires throughout the trial
- Willing to refrain from participation in any other research trial for the duration of this trial
- Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures
- 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
- 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
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding, or having breastfed within 3 months prior to screening
- Receipt of any investigational agent within 60 days prior to screening
- Previously participated in any HIV vaccine trial
- Untreated urogenital infections within 2 weeks prior to enrollment
- Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction
- Pap smear result at screening that requires cryotherapy, biopsy or treatment (other than for infection)
- History of symptomatic or asymptomatic HSV-2
- Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline
- Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal intercourse; or urogenital surgery within 90 days prior to enrollment
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
- Any serious acute, chronic or progressive disease
- Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
Key Trial Info
Start Date :
July 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2011
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00799058
Start Date
July 6 2009
End Date
January 8 2011
Last Update
October 25 2022
Active Locations (5)
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1
University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)
Birmingham, Alabama, United States, 35294
2
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
3
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
4
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201