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

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00799058
First received: November 26, 2008
Last updated: June 24, 2011
Last verified: June 2011

November 26, 2008
June 24, 2011
June 2009
April 2011   (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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
Same as current
Not Provided
Not Provided
 
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
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.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
HIV-1 Infections
  • Drug: dapivirine
    dapivirine gel 4789, 0.05%, 2.5g applied once daily
    Other Name: TMC120
  • Drug: dapivirine
    dapivirine gel 4759, 0.05%, 2.5g applied once daily
    Other Name: TMC120
  • Drug: placebo
    HEC-based universal placebo gel, 2.5g applied once daily
  • Active Comparator: dapivirine gel 4789
    Intervention: Drug: dapivirine
  • Active Comparator: dapivirine gel 4759
    Intervention: Drug: dapivirine
  • Placebo Comparator: placebo gel
    Intervention: 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
April 2011
April 2011   (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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00799058
IPM 020
Yes
Zeda Rosenberg, International Partnership for Microbicides
International Partnership for Microbicides, Inc.
Not Provided
Study Chair: Dr Annalene Nel International Partnership for Microbicides
International Partnership for Microbicides, Inc.
June 2011

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