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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

November 26, 2008
January 26, 2017
June 2009
June 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00799058 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
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
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
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.
Interventional
Phase 1
Phase 2
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
HIV-1 Infections
  • Drug: dapivirine
    dapivirine gel 4789, 0.05%, 2.5g applied once daily
    Other Name: TMC120
  • Drug: dapivirine gel 4759
    dapivirine gel 4759, 0.05%, 2.5g applied once daily
    Other Name: TMC120
  • Drug: Drug placebo
    HEC-based universal placebo gel, 2.5g applied once daily
    Other Name: HEC-based placebo gel, 2.5g
  • Active Comparator: dapivirine gel 4789
    will be applied by participants once daily for 12-weeks treatment period
    Intervention: Drug: dapivirine
  • Active Comparator: dapivirine gel 4759
    Will be applied by participants once daily for12-weeks treatment period
    Intervention: Drug: dapivirine gel 4759
  • Placebo Comparator: HEC-based placebo gel, 2.5g containing no Dapivirine
    Will be applied once daily for 12-weeks treatment period
    Intervention: Drug: Drug placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
November 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00799058
IPM 020
Yes
Not Provided
No
Not Provided
International Partnership for Microbicides, Inc.
International Partnership for Microbicides, Inc.
Not Provided
Study Chair: Dr Annalene Nel International Partnership for Microbicides
International Partnership for Microbicides, Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP