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A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00799058
First received: November 26, 2008
Last updated: January 26, 2017
Last verified: December 2016
  Purpose
A Multi-Center, Randomized, Double-Blind, PlaceboControlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring with Dapivirine for the Prevention of HIV-1 Infection in Women

Condition Intervention Phase
HIV-1 Infections
Drug: dapivirine
Drug: dapivirine gel 4759
Drug: Drug placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All enrolled participants will apply gel on a daily basis for 12 weeks, with clinical follow-up visits at weeks 2, 4,8 and 12 to monitor safety and acceptability, and a final visit 4 weeks post gel discontinuation (Visit 6, week 16) Dapivirine concentration will be measured in blood and vaginal fluid and cervical tissue.
Masking: Participant, Investigator
Masking Description:
Potential participants who provide inform concent will be invited to screen for the trail. All participants who consent to participate in the trail and meet specified inclusion /exclusion criteria will be invited to enroll.. At enrollment women will be randomly assigned in a1:1: 1 ratio to one of three groups.
Primary Purpose: Prevention
Official Title: A Multi-Center, Randomized, Double-Blind, PlaceboControlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring With Dapivirine for the Prevention of HIV-1 Infection in 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 ]

Secondary Outcome Measures:
  • Changes in the vaginal flora and vaginal pH [ Time Frame: 12 weeks ]
  • The distribution of dapivirine levels observed in plasma, vaginal fluid and vaginal tissue samples at each specified time point [ Time Frame: 12 weeks ]

Enrollment: 180
Study Start Date: June 2009
Study Completion Date: November 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dapivirine gel 4789
will be applied by participants once daily for 12-weeks treatment period
Drug: dapivirine
dapivirine gel 4789, 0.05%, 2.5g applied once daily
Other Name: TMC120
Active Comparator: dapivirine gel 4759
Will be applied by participants once daily for12-weeks treatment period
Drug: dapivirine gel 4759
dapivirine gel 4759, 0.05%, 2.5g applied once daily
Other Name: TMC120
Placebo Comparator: HEC-based placebo gel, 2.5g containing no Dapivirine
Will be applied once daily for 12-weeks treatment period
Drug: Drug placebo
HEC-based universal placebo gel, 2.5g applied once daily
Other Name: HEC-based placebo gel, 2.5g

Detailed Description:
IPM 020 is a double-blind, randomized, placebo-controlled Phase 3 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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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: NCT00799058

Locations
United States, Alabama
University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)
Birmingham, Alabama, United States, 35294
United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
United States, New York
Albert Einstein College of Medicine
New York, New York, United States, 10461
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Chair: Dr Annalene Nel International Partnership for Microbicides
  More Information

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT00799058     History of Changes
Other Study ID Numbers: IPM 020
Study First Received: November 26, 2008
Last Updated: January 26, 2017
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on May 25, 2017