Clinical trial NCT00613249: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV-1 Infection
HIV Seronegativity
Lead sponsor: International Partnership for Microbicides, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples
timeFrame: 11 days
measure: Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Life Science Services Research Unit Stuivenberg
Study officials:
affiliation: IPM
name: Dr. Annalene Nel
role: STUDY_DIRECTOR
References:
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