A Safety Study of Dapivirine Vaginal Ring in Africa

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01071174
First received: February 17, 2010
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
HIV Infections
Other: Dapivirine
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acceptability of the product determined by questionnaire. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01071174

Locations
Kenya
Kenya Medical Research Institute (KEMRI)
Kisumu, Kenya
Malawi
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
Tanzania
Kilimanjaro Christian Medical Centre (KCMC)
Moshi, Tanzania
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Dr Annalene Nel IPM
  More Information

No publications provided

Responsible Party: Annalene Nel, MBChB, PhD, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT01071174     History of Changes
Other Study ID Numbers: IPM 015
Study First Received: February 17, 2010
Last Updated: August 1, 2011
Health Authority: South Africa: Medicines Control Council
Malawi: College of Medicine Research and Ethics Committee
Rwanda: Ministry of Health
Tanzania: Food & Drug Administration
Kenya: Institutional Review Board
Zambia: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 16, 2014