A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01337570
First received: April 13, 2011
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Other: Dapivirine
Other: Placebo
Drug: Dapivirine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    This will be measured by self-reports, physical examination, safety laboratory tests and other specialised investigations.


Secondary Outcome Measures:
  • Adherence to the protocol-specific product regimen as determined by self-reported diary cards and questionnaires. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • The incidence of curable STI's or pregnancy as determined by STI testing and pregnancy testing. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapivirine
Vaginal ring containing 25mg of dapivirine
Other: Dapivirine
Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months
Drug: Dapivirine
Placebo Comparator: Placebo Ring
Vaginal ring containing no drug substance
Other: Placebo
Vaginal Ring containing no drug substance

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337570

Locations
Malawi
College of Medicine - Johns Hopkins Project (JHP)
Blantyre, Malawi
Rwanda
African University Clinical Research Centre
Kigali, Rwanda
South Africa
Qhakaza Mbokodo
Ladysmith, KwaZulu Natal, South Africa, 3370
Madibeng Centre for Research (MCR)
Brits, South Africa, 0250
Zimbabwe
African University Clinical Research Centre
Mutare, Zimbabwe
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Annalene Nel IPM
  More Information

No publications provided

Responsible Party: Annalene Nel, MBChB, PhD, International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01337570     History of Changes
Other Study ID Numbers: IPM 009A
Study First Received: April 13, 2011
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Malawi: College of Medicine Research and Ethics Committee
Rwanda: Ministry of Health
Zimbabwe: Medicines Control Authority of Zimbabwe

Keywords provided by International Partnership for Microbicides, Inc.:
HIV Infections
Anti-HIV agents
HIV-1

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014