An Expanded Safety Study of Dapivirine Gel 4789 in Africa

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00917904
First received: June 8, 2009
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.


Condition Intervention Phase
HIV Infections
Acquired Immunodeficiency Syndrome
Healthy
Drug: dapivirine
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 4789, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Questionnaires concerning acceptability and adherence to daily use of vaginal gel. [ Time Frame: Week 0, 2, 6 & 10 ] [ Designated as safety issue: No ]
  • Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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). IPM014B is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4789, 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.

  Eligibility

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

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
  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: NCT00917904

Locations
South Africa
Be Part Clinic, Mbekweni
Paarl, Eastern Cape, South Africa
Madibeng Centre for Research
Brits, North West Province, South Africa
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, Western Cape, South Africa, 7975
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Dr Annalene Nel IPM
  More Information

Additional Information:
No publications provided

Responsible Party: Annalene Nel, IPM
ClinicalTrials.gov Identifier: NCT00917904     History of Changes
Other Study ID Numbers: IPM 014B
Study First Received: June 8, 2009
Last Updated: December 13, 2011
Health Authority: South Africa: Medicines Control Council

Keywords provided by International Partnership for Microbicides, Inc.:
HIV Infections
Acquired Immunodeficiency Syndrome
Healthy
HIV seronegativity

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

ClinicalTrials.gov processed this record on October 21, 2014