Clinical Trials

MainTitle

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

This study has been completed
Sponsor
International Partnership for Microbicides, Inc.


Information provided by (Responsible Party)
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier
NCT00613249

First received: January 31, 2008
Last updated: March 26, 2009
Last Verified: March 2009
History of Changes
Purpose

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
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.

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 ]
  • Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events [ Time Frame: 14 days ]

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

Eligibility

Ages Eligible for Study: 18 Years to 40 Years  
Sexes 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

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

More Information


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  

Keywords provided by International Partnership for Microbicides, Inc.:

HIV-1 Infection
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.