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A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
This study is currently recruiting participants.
Verified by International Partnership for Microbicides, Inc., December 2009
First Received: November 26, 2008   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: NCT00799058
  Purpose

IPM 020 is a double-blind, randomized, placebo-controlled Phase I/II expanded safety trial being conducted at 5 research centers in the United States among approximately 180 healthy, sexually active, HIV-negative women to assess the safety of Dapivirine Gel 4759, 0.05% 2.5g and Dapivirine Gel 4789, 0.05% 2.5g as compared to the HEC-based universal placebo.


Condition Intervention Phase
HIV-1 Infections
Drug: dapivirine
Drug: placebo
Phase I
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title: A Double-blind, Randomized, Placebo-controlled Phase I/II Trial to Evaluate the Safety of Dapivirine Gel, 0.05%, 2.5g and Dapivirine Gel 2759, 0.05%, 2.5g Formulations as Compared to the Vaginal HEC-based Universal Placebo Gel, 2.5g in Healthy, HIV-negative Women.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The proportion of women who have abnormal observations at each visit during the pelvic/speculum examination and colposcopy, and the proportion of women who report at least one adverse event. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in the vaginal flora and vaginal pH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The distribution of dapivirine levels observed in plasma, vaginal fluid and vaginal tissue samples at each specified time point [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dapivirine gel 4789: Active Comparator Drug: dapivirine
dapivirine gel 4789, 0.05%, 2.5g applied once daily
dapivirine gel 4759: Active Comparator Drug: dapivirine
dapivirine gel 4759, 0.05%, 2.5g applied once daily
placebo gel: Placebo Comparator Drug: placebo
HEC-based universal placebo gel, 2.5g applied once daily

  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 trial
  3. Healthy and self-reported sexually active
  4. HIV-negative as determined by an HIV test at time of enrollment
  5. Willing to be on a stable form of contraception
  6. In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle
  7. Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff
  8. Asymptomatic for genital infections at the time of enrollment
  9. Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial.
  10. Documentation of no abnormality on Pap smear within 90 days prior to randomization;
  11. Willing to answer acceptability and adherence questionnaires throughout the trial
  12. Willing to refrain from participation in any other research trial for the duration of this trial
  13. Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures
  14. Willing to abstain from all the following criteria beginning 48 hours prior to each trial visit:

    • Vaginal intercourse
    • Oral contact with her genitalia
    • Internal vaginal washing
    • Penetration of the vagina by fingers, sex toys, or any other objects, including medications
  15. Willing to abstain from all of the following for 3 days after biopsy procedures:

    • Vaginal intercourse
    • Oral contact with her genitalia
    • Internal vaginal washing
    • Penetration of the vagina by fingers, sex toys, or any other objects, including medications

Exclusion Criteria:

  1. Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening
  2. Currently breast-feeding, or having breastfed within 3 months prior to screening
  3. Receipt of any investigational agent within 60 days prior to screening
  4. Previously participated in any HIV vaccine trial
  5. Untreated urogenital infections within 2 weeks prior to enrollment
  6. Presence of any 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, or urethral obstruction
  8. Pap smear result at screening that requires cryotherapy, biopsy or treatment (other than for infection)
  9. History of symptomatic or asymptomatic HSV-2
  10. Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline
  11. Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal intercourse; or urogenital surgery within 90 days prior to enrollment
  12. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
  13. Any serious acute, chronic or progressive disease
  14. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799058

Locations
United States, Alabama
University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS) Recruiting
Birmingham, Alabama, United States, 35294
Contact: Hala Fawal     205-975-8699     hfawal@uab.edu    
Principal Investigator: Dr Craig Hoesley            
United States, California
Harbor-UCLA Medical Center Not yet recruiting
Torrance, California, United States, 90502
Contact: Susan Ballagh, MD     310-320-6043        
Principal Investigator: Susan Ballagh, MD            
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Ellen Verlen     312-413-5897     everle1@uic.edu    
Principal Investigator: Dr Richard Novak            
United States, Maryland
SNBL Clinical Pharmacology Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Katrina Crawford     410-706-8835     kcrawford@snbl-cpc.com    
Principal Investigator: Dr Stephen Bart            
United States, New York
Albert Einstein College of Medicine Recruiting
New York, New York, United States, 10461
Contact: Marla Keller, MD     718-430-3240        
Principal Investigator: Marla Keller, MD            
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Chair: Dr Annalene Nel International Partnership for Microbicides
  More Information

No publications provided

Responsible Party: International Partnership for Microbicides ( Zeda Rosenberg )
Study ID Numbers: IPM 020
Study First Received: November 26, 2008
Last Updated: December 16, 2009
ClinicalTrials.gov Identifier: NCT00799058     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on February 08, 2010