NCT01337583
Withdrawn
Phase 3
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Safety and Efficacy Trial of a Vaginal Matrix Ring With Dapivirine for the Prevention of HIV-1 Infection in Women
Overview
- Phase
- Phase 3
- Intervention
- Dapivirine
- Conditions
- HIV Infections
- Sponsor
- International Partnership for Microbicides, Inc.
- Locations
- 5
- Primary Endpoint
- Efficacy as determined by HIV-1 seroconversion rate per person-years of product use, measured at the end of the investigational product use period.
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
Brief Summary
This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women \>18 and \<40 years of age who can provide informed consent
- •Available for all visits and consent to follow all procedures scheduled for the trial
- •Generally healthy and self-reported sexually active (defined as an average of at least one penetrative penile vaginal coital act per month for the last 3 months prior to enrolment)
- •HIV-negative as determined by the HIV algorithm applied at screening and enrolment
- •On a stable form of contraception and willing to continue on stable contraception for the duration of the clinical trial;
- •Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant treatable STI, she must have initiated treatment at least 1 week prior to enrolment and have completed the full course of treatment)
- •Willing to answer questions about adherence, sexual behaviour, vaginal practices and ring acceptability;
- •Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures (e.g., by home visit or telephone; or via family or close neighbour contacts \[confidentiality to be maintained\])
- •Willing to refrain from participation in another research trial using drugs, vaccines, medical devices, microbicides or oral pre-exposure prophylaxis investigational drugs for the duration of the IPM 009B trial;
- •In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses;
Exclusion Criteria
- •Currently pregnant or last pregnancy within 3 months prior to screening;
- •Currently breast-feeding
- •Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening
- •Previously participated or currently participating in any HIV vaccine trial
- •Untreated, clinically significant urogenital infections (either symptomatic or asymptomatic), e.g., urinary tract or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to enrolment
- •History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
- •Any gynaecological surgery within 90 days prior to enrolment
- •Any Grade 3 or 4 baseline haematology, chemistry or urinalysis laboratory value according to the DAIDS Table for Grading Adverse Experiences, or clinically significant Grade 2 findings
- •Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or a silicone elastomer
- •Any history of diabetes mellitus and chronic use of oral steroid therapy and any uncontrolled serious chronic or progressive disease
Arms & Interventions
Dapivirine
Vaginal ring containing 25mg of dapivirine
Intervention: Dapivirine
Placebo Ring
Vaginal ring containing no drug substance
Intervention: Placebo
Outcomes
Primary Outcomes
Efficacy as determined by HIV-1 seroconversion rate per person-years of product use, measured at the end of the investigational product use period.
Time Frame: 15 months
The primary endpoint is HIV-1 seroconversion measured by rapid and specialized laboratory tests according to a comprehensive HIV testing algorithm. This algorithm employs a series of high specificity and high sensitivity immunoassay-based HIV blood tests that minimize the chance of false positive results to determine if a subject is positive for HIV. Endpoint confirmation of HIV infection is by Western blot.
Safety as determined by grade 3 and 4 AE's, clinically significant grade 2 laboratory findings (based on DAIDS grading) and all serious AE's.
Time Frame: 15 months
This will be measured by self-reports, physical examination, safety laboratory tests and other specialised investigations.
Secondary Outcomes
- Adherence to the protocol-specific product regimen as determined by self-reported diary cards and questionnaires.(15 months)
- The incidence of curable STI's or pregnancy as determined by STI testing and pregnancy testing.(15 months)
Study Sites (5)
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