search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Dapivirine Gel 4750, 0.05%, 2.5g
Dapivirine Gel 4789, 0.05%, 2.5g
HEC-based Placebo Gel
Sponsored by
International Partnership for Microbicides, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV-1 Infection, HIV Seronegativity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • SGS Life Science Services Research Unit Stuivenberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples
Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events

Secondary Outcome Measures

Full Information

First Posted
January 31, 2008
Last Updated
March 26, 2009
Sponsor
International Partnership for Microbicides, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00613249
Brief Title
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
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 Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Partnership for Microbicides, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1 Infection, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dapivirine Gel 4750, 0.05%, 2.5g
Intervention Description
intravaginal gel, dosed daily
Intervention Type
Drug
Intervention Name(s)
Dapivirine Gel 4789, 0.05%, 2.5g
Intervention Description
intravaginal gel, dosed daily
Intervention Type
Drug
Intervention Name(s)
HEC-based Placebo Gel
Intervention Description
intravaginal gel, dosed daily
Primary Outcome Measure Information:
Title
Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples
Time Frame
11 days
Title
Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events
Time Frame
14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Annalene Nel
Organizational Affiliation
IPM
Official's Role
Study Director
Facility Information:
Facility Name
SGS Life Science Services Research Unit Stuivenberg
City
Antwerp
ZIP/Postal Code
B-2060
Country
Belgium

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs