- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01337570
A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa
June 8, 2012 updated by: International Partnership for Microbicides, Inc.
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Blantyre, Malawi
- College of Medicine - Johns Hopkins Project (JHP)
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Kigali, Rwanda
- African University Clinical Research Centre
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Brits, South Africa, 0250
- Madibeng Centre for Research (MCR)
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KwaZulu Natal
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Ladysmith, KwaZulu Natal, South Africa, 3370
- Qhakaza Mbokodo
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Mutare, Zimbabwe
- African University Clinical Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Dapivirine
Vaginal ring containing 25mg of dapivirine
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Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months
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PLACEBO_COMPARATOR: Placebo Ring
Vaginal ring containing no drug substance
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Vaginal Ring containing no drug substance
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Efficacy as determined by the proportion of women in each arm HIV-1 seroconversion rate per person-years of product use, measured at the end of the investigational product use period.
Time Frame: 15 months
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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.
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15 months
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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
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This will be measured by self-reports, physical examination, safety laboratory tests and other specialised investigations.
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15 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Adherence to the protocol-specific product regimen as determined by self-reported diary cards and questionnaires.
Time Frame: 15 months
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15 months
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The incidence of curable STI's or pregnancy as determined by STI testing and pregnancy testing.
Time Frame: 15 months
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15 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ANTICIPATED)
July 1, 2014
Study Completion (ANTICIPATED)
July 1, 2014
Study Registration Dates
First Submitted
April 13, 2011
First Submitted That Met QC Criteria
April 15, 2011
First Posted (ESTIMATE)
April 19, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
June 11, 2012
Last Update Submitted That Met QC Criteria
June 8, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Infections
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dapivirine
Other Study ID Numbers
- IPM 009A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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