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An Expanded Safety Study of Dapivirine Gel 4789 in Africa
This study is currently recruiting participants.
Verified by International Partnership for Microbicides, Inc., December 2009
First Received: June 8, 2009   Last Updated: December 16, 2009   History of Changes
Sponsor: International Partnership for Microbicides, Inc.
Information provided by: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT00917904
  Purpose

The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.


Condition Intervention Phase
HIV Infections
Acquired Immunodeficiency Syndrome
Healthy
Drug: dapivirine gel 4789, 0.05%, 2.5g
Drug: vehicle placebo gel, 2.5g
Phase I
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
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 ]

Estimated Enrollment: 320
Study Start Date: July 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
vehicle placebo gel: Placebo Comparator Drug: vehicle placebo gel, 2.5g
dosage form: vaginal gel frequency: once daily duration: 6 weeks
dapivirine gel: Experimental Drug: dapivirine gel 4789, 0.05%, 2.5g
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917904

Contacts
Contact: Madi Albertse +27 (0) 21 860 2300 malbertse@ipm-microbicides.org.za

Locations
Kenya
Kenya Medical Research Institute Not yet recruiting
Kisumu, Kenya
Principal Investigator: Dr Elizabeth Bukusi            
Sub-Investigator: Dr Maureen Adudans            
Sub-Investigator: Dr. Craig Cohen            
Sub-Investigator: Dr. Betty Njoroge            
Malawi
Johns Hopkins Project, College of Medicine Not yet recruiting
Blantyre, Malawi
Principal Investigator: Dr Bonus Makanani            
Sub-Investigator: Dr Luis Gadama            
Rwanda
Projet Ubuzima Not yet recruiting
Kigali, Rwanda
Contact: Joseph Vyankandondera, MD     +250 503431     vyankajo@yahoo.fr    
Principal Investigator: Dr. Joseph Vyankandondera            
Sub-Investigator: Janneke van de Wijgert, PhD            
Sub-Investigator: Dr Justin Ntirushwa            
South Africa, Eastern Cape
Be Part Clinic, Mbekweni Recruiting
Paarl, Eastern Cape, South Africa
Principal Investigator: Dr Elizabeth Hellstrom            
Sub-Investigator: Dr. Chrisna Anderson            
Sub-Investigator: Dr. Cornelis Grobelaar            
Sub-Investigator: Dr. Inge Paschke            
South Africa, KwaZulu Natal
Qhakaza Mbokodo Not yet recruiting
Ladysmith, KwaZulu Natal, South Africa
Principal Investigator: Dr. Joshua Matambo            
Principal Investigator: Dr. Philip Kotze            
Sub-Investigator: Dr. Sidney Sibiya            
Prevention for HIV and AIDS Project Not yet recruiting
Pinetown, KwaZulu Natal, South Africa
Principal Investigator: Dr. Derek Arbuckle            
Sub-Investigator: Dr. Michael Robinson            
South Africa, North West Province
Madibeng Centre for Research Recruiting
Brits, North West Province, South Africa
Principal Investigator: Dr. Cheryl Louw            
Sub-Investigator: Dr Francis Anthonyrajah            
Sub-Investigator: Prof. Johannes Hugo, MBChB            
South Africa, Western Cape
Desmond Tutu HIV Foundation, Masiphumelele Recruiting
Cape Town, Western Cape, South Africa, 7975
Principal Investigator: Dr. Linda-Gail Bekker            
Sub-Investigator: Dr. Jennifer Pitt            
Desmond Tutu HIV Foundation, Nyanga Not yet recruiting
Cape Town, Western Cape, South Africa
Principal Investigator: Dr. Linda-Gail Bekker            
Sub-Investigator: Dr Danielle Crida            
Sub-Investigator: Dr. Llewellyn Fleurs            
Sub-Investigator: Dr. Andrew Scheibe            
Sub-Investigator: Dr. Jennifer Pitt            
Tanzania
Kilimanjaro Christian Medical Centre Not yet recruiting
Moshi, Tanzania
Contact: Tara Mtuy     +255 272 750663        
Principal Investigator: Dr Gileard Masenga            
Principal Investigator: Prof Saidi Kapiga            
Sub-Investigator: Dr Sarah Chiduo            
Sub-Investigator: Dr Charles Mmbando            
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Dr Annalene Nel IPM
  More Information

Additional Information:
No publications provided

Responsible Party: IPM ( Zeda Rosenberg, ScD )
Study ID Numbers: IPM 014B
Study First Received: June 8, 2009
Last Updated: December 16, 2009
ClinicalTrials.gov Identifier: NCT00917904     History of Changes
Health Authority: South Africa: Medicines Control Council;   Tanzania: Food & Drug Administration;   Malawi: College of Medicine Research and Ethics Committee;   Kenya: Ministry of Health;   Rwanda: Ethics Committee

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

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

ClinicalTrials.gov processed this record on February 08, 2010