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An Expanded Safety Study of Dapivirine Gel 4759 in Africa

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ClinicalTrials.gov Identifier: NCT00917891
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : September 12, 2011
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Brief Summary:
The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.

Condition or disease Intervention/treatment Phase
HIV Infections Acquired Immunodeficiency Syndrome Drug: dapivirine Drug: placebo Phase 1 Phase 2

Detailed Description:
To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014A is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4759, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4759, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4759, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.
Study Start Date : November 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Placebo Comparator: vehicle placebo gel Drug: placebo

dosage form: vaginal gel

frequency: once daily

duration: 6 weeks

Experimental: dapivirine gel Drug: dapivirine

dosage form: vaginal gel

dosage: 1.25mg dapivirine/day

frequency: once daily

duration: 6 weeks

Primary Outcome Measures :
  1. Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing. [ Time Frame: Week 0, 1, 2, 4, 6 & 10 ]
  2. Safety laboratory tests [ Time Frame: enrollment & last day of gel use ]
  3. Adverse event/serious adverse event reports [ Time Frame: throughout study ]

Secondary Outcome Measures :
  1. Questionnaires concerning acceptability and adherence to daily use of vaginal gel. [ Time Frame: Week 0, 2, 6 & 10 ]
  2. Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews. [ Time Frame: throughout study ]

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:

  1. Women 18 to 40 years of age inclusive who can give written informed consent
  2. Available for all visits and consent to follow all procedures scheduled for the study
  3. Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method
  4. Healthy and self-reported sexually active
  5. HIV-negative as determined by a HIV rapid test at time of enrollment
  6. On a stable form of contraception and willing to continue on this stable method of contraception, OR, Have undergone surgical sterilisation at least 3 months prior to enrollment
  7. 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 36 days between menses
  8. Upon pelvic/speculum examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the investigator
  9. Asymptomatic for genital infections at the time of enrollment
  10. Willing to refrain from use of vaginal products or objects within 14 days prior to enrollment and for the duration of the study
  11. Willing to answer acceptability and adherence questionnaires throughout the study
  12. Willing to refrain from participation in any other research study for the duration of this study
  13. Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures

Exclusion Criteria:

  1. Currently pregnant or last pregnancy outcome within 3 months prior to enrolment
  2. Currently breast-feeding
  3. Participated in any other research study within 60 days prior to screening
  4. Previously participated in any HIV vaccine study
  5. Untreated urogenital infections (either symptomatic or asymptomatic) within 2 weeks prior to enrollment
  6. Presence of abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
  7. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction
  8. Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
  9. Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences
  10. Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment
  11. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
  12. Any serious acute, chronic or progressive disease
  13. 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 ClinicalTrials.gov identifier (NCT number): NCT00917891

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Kenya Medical Research Institute
Kisumu, Kenya
Johns Hopkins Project, College of Medicine
Blantyre, Malawi
Projet Ubuzima
Kigali, Rwanda
South Africa
Be Part Clinic, Mbekweni
Paarl, Eastern Cape, South Africa
Qhakaza Mbokodo
Ladysmith, KwaZulu Natal, South Africa
Prevention for HIV and AIDS Project
Pinetown, KwaZulu Natal, South Africa
Ndlela HIV Research and Clinical Tirals Unit
Agincourt, Mpumalanga, South Africa
Madibeng Centre for Research
Brits, North West Province, South Africa
Desmond Tutu HIV Foundation, Nyanga
Cape Town, Western Cape, South Africa
Kilimanjaro Christian Medical Centre
Moshi, Tanzania
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
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Study Director: Dr Annalene Nel IPM
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Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT00917891    
Other Study ID Numbers: IPM 014A
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: September 2011
Keywords provided by International Partnership for Microbicides, Inc.:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV seronegativity
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immune System Diseases
Slow Virus Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents