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

International Partnership for Microbicides (IPM)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: Dapivirine Gel 4750, 0.05%, 2.5g

Drug: Dapivirine Gel 4789, 0.05%, 2.5g

Drug: HEC-based Placebo Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00613249

IPM 012

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts 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