A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV-1 Infections

In brief

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 HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Key facts

Study ID

NCT00799058

Run by

International Partnership for Microbicides, Inc.

People needed

128

Starts

2009-07-06

Expected to finish

2011-01-08

Last updated by the study team

2022-10-25

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS) — Birmingham, Alabama, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• SNBL Clinical Pharmacology Center — Baltimore, Maryland, United States
• Albert Einstein College of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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