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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799058
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Brief Summary:
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Condition or disease Intervention/treatment Phase
HIV-1 Infections Drug: dapivirine 4789 Drug: dapivirine gel 4759 Drug: Drug placebo Phase 1 Phase 2

Detailed Description:
This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
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: Double (Participant, Investigator)
Masking Description: Potential participants who provide inform consent will be invited to screen for the trial. All participants who consent to participate in the trial and meet specified inclusion/exclusion criteria will be invited to enrol. At enrolment women will be randomly assigned in a 1:1:1 ratio to one of three groups.
Primary Purpose: Prevention
Official Title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN
Study Start Date : June 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: dapivirine gel 4789
will be applied by participants once daily for 12-weeks treatment period
Drug: dapivirine 4789
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




Primary Outcome Measures :
  1. 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 :
  1. Changes in the vaginal flora and vaginal pH [ Time Frame: 12 weeks ]
  2. The distribution of dapivirine levels observed in plasma, vaginal fluid and vaginal tissue samples at each specified time point [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799058


Locations
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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
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Study Chair: Dr Annalene Nel International Partnership for Microbicides
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Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT00799058    
Other Study ID Numbers: IPM 020
First Posted: November 27, 2008    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1 infections
Additional relevant MeSH terms:
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Infection
Dapivirine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents