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A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels

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. Identifier: NCT00613249
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : March 27, 2009
Information provided by:
International Partnership for Microbicides, Inc.

Brief Summary:
IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day washout period and then 10 consecutive days); and to assess the safety of these gels as compared to the intravaginal HEC-based universal placebo gel.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Dapivirine Gel 4750, 0.05%, 2.5g Drug: Dapivirine Gel 4789, 0.05%, 2.5g Drug: HEC-based Placebo Gel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled Phase I Study to Compare the Pharmacokinetics of Intravaginal Dapivirine Gel 4750, 0.05%, 2.5g and Dapivirine Gel 4789, 0.05%, 2.5g Formulations and to Assess the Safety as Compared to the Intravaginal HEC-Based Universal Placebo Gel, 2.5g in Healthy HIV-Negative Women.
Study Start Date : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: A Drug: Dapivirine Gel 4750, 0.05%, 2.5g
intravaginal gel, dosed daily

Experimental: B Drug: Dapivirine Gel 4789, 0.05%, 2.5g
intravaginal gel, dosed daily

Placebo Comparator: C Drug: HEC-based Placebo Gel
intravaginal gel, dosed daily

Primary Outcome Measures :
  1. Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples [ Time Frame: 11 days ]
  2. Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events [ Time Frame: 14 days ]

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

Inclusion Criteria:

  • Women between 18 and 40 years of age, inclusive
  • Willing and able to give written informed consent
  • Available for all visits and consent to follow all procedures
  • Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function
  • HIV-negative as determined by a HIV-1 ELISA test at enrollment
  • Willing to abstain from sexual activity for the duration of the study
  • On stable oral contraceptive regimen for 2 months prior to enrollment and willing to continue
  • Upon pelvic/speculum examination, the cervix and vagina appear normal
  • Willing to refrain from the use of vaginal products from 14 days prior to enrollment and for the duration of the study

Exclusion Criteria:

  • History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact adherence with protocol requirements
  • History of sensitivity/allergy to any component of the study product or to latex
  • Currently pregnant or breast-feeing, or within 3 months of last pregnancy outcome
  • Currently or within one month of participating in any other clinical research study
  • History or current diagnosis and/or treatment for a STD within the last three months prior to enrollment
  • Current vulvar, vaginal or cervical symptoms/abnormalities as determined by pelvic/speculum exam or colposcopy that could influence the study results
  • History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months
  • Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
  • Smoking more than 10 cigarettes a day

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 identifier (NCT number): NCT00613249

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SGS Life Science Services Research Unit Stuivenberg
Antwerp, Belgium, B-2060
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
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Study Director: Dr. Annalene Nel IPM
Publications of Results:
Nel A, Smythe S, Habibi S, Romano J. 2009. Comparison of Safety and PK of Two Formulations of Dapivirine Vaginal Gel in Healthy, HIV-Negative Women [abstract]. 16th Conference on Retroviruses and Opportunistic Infections; 2009 Feb 8-11; Montreal. Available from:

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Responsible Party: Dr. Annalene Nel, International Partnership for Microbicides Identifier: NCT00613249    
Other Study ID Numbers: IPM 012
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009
Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1 Infection
HIV Seronegativity
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents