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A Safety Study of Dapivirine Vaginal Ring in Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071174
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : August 2, 2011
Information provided by:
International Partnership for Microbicides, Inc.

Brief Summary:
This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.

Condition or disease Intervention/treatment Phase
HIV Infections Other: Dapivirine Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.
Study Start Date : April 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Placebo Comparator: Placebo Ring
Vaginal Ring containing no drug substance
Other: Placebo
Vaginal Ring containing no drug substance

Experimental: Dapivirine Ring
Dapivirine Vaginal Ring 25mg
Other: Dapivirine
Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)

Primary Outcome Measures :
  1. Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Acceptability of the product determined by questionnaire. [ Time Frame: 16 weeks ]
  2. Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women between 18 and 40 years of age inclusive who can provide informed consent
  • Available for all visits and consent to follow all procedures scheduled for the study
  • Healthy and self-reported sexually active
  • HIV-negative
  • On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment
  • 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
  • Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator
  • Asymptomatic for genital infections at the time of enrolment
  • Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study
  • Willing to answer to acceptability, adherence and behavioural assessments throughout the study
  • Willing to refrain from participation in any other research study for the duration of their participation
  • Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures

Exclusion Criteria:

  • Currently pregnant or last pregnancy within 3 months prior to enrolment
  • Currently breast-feeding
  • Participated in any other research study within 60 days prior to screening
  • Previously participated in any HIV vaccine study
  • Untreated urogenital infections within 2 weeks prior to enrolment
  • 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, incontinence or urge incontinence
  • Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation
  • Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events
  • Any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
  • Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone elastomer
  • Any serious acute, chronic or progressive disease
  • Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071174

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Kenya Medical Research Institute (KEMRI)
Kisumu, Kenya
University of North Carolina Project
Lilongwe, Malawi
South Africa
Reproductive Health and HIV Research Unit (RHRU)
Edendale, Kwazulu Natal, South Africa
Qhakaza Mbokodo
Ladysmith, Kwazulu Natal, South Africa
Prevention for HIV and AIDS Project (PHIVA)
Pinetown, Kwazulu Natal, South Africa
Madibeng Centre for Research
Brits, North West, South Africa
Desmond Tutu HIV Foundation Masiphumelele
Cape Town, Western Cape, South Africa
Desmond Tutu HIV Foundation Nyanga
Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre Mbekweni
Paarl, Western Cape, South Africa
Kilimanjaro Christian Medical Centre (KCMC)
Moshi, Tanzania
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
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Study Director: Dr Annalene Nel IPM
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Annalene Nel, MBChB, PhD, International Partnership for Microbicides Identifier: NCT01071174    
Other Study ID Numbers: IPM 015
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: August 2011
Keywords provided by International Partnership for Microbicides, Inc.:
HIV infections
Anti-HIV agents
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents