A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

NCT ID: NCT01337570

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-07-31

Brief Summary

This is a double-blind, randomized, placebo-controlled Phase III study to assess the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dapivirine

Vaginal ring containing 25mg of dapivirine

Group Type: EXPERIMENTAL

Dapivirine

Intervention Type: OTHER

Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months

Dapivirine

Intervention Type: DRUG

Placebo Ring

Vaginal ring containing no drug substance

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Vaginal Ring containing no drug substance

Interventions

Dapivirine

Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months

Intervention Type: OTHER

Placebo

Vaginal Ring containing no drug substance

Intervention Type: OTHER

Dapivirine

Intervention Type: DRUG

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 as defined within section 5.4 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 009A 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;
• Willing to refrain from use of vaginal products or objects including spermicides, tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches and drying agents within 14 days from enrolment and for the duration of the trial.

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
• Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation [this includes any findings of atypical squamous cells of undetermined significance (ASCUS)]
• Any condition(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives, or adherence to trial requirements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

International Partnership for Microbicides, Inc.

Principal Investigators

Annalene Nel

Role: STUDY_DIRECTOR

Beijing Immupeutics Medicine Technology Limited

Locations

College of Medicine - Johns Hopkins Project (JHP)

Blantyre, , Malawi

African University Clinical Research Centre

Kigali, , Rwanda

Qhakaza Mbokodo

Ladysmith, KwaZulu-Natal, South Africa

Madibeng Centre for Research (MCR)

Brits, , South Africa

African University Clinical Research Centre

Mutare, , Zimbabwe

Countries

Malawi; Rwanda; South Africa; Zimbabwe

Other Identifiers

IPM 009A

Identifier Type: -

Identifier Source: org_study_id