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

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00613249
First received: January 31, 2008
Last updated: March 26, 2009
Last verified: March 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00613249

Locations
Belgium
SGS Life Science Services Research Unit Stuivenberg
Antwerp, Belgium, B-2060
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Dr. Annalene Nel IPM
  More Information

Publications:
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: http://www.retroconference.org/2009/PDFs/1065.pdf

Responsible Party: Dr. Annalene Nel, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT00613249     History of Changes
Other Study ID Numbers: IPM 012
Study First Received: January 31, 2008
Last Updated: March 26, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

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

ClinicalTrials.gov processed this record on July 22, 2014