A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

NCT00469768 | Completed Phase 1

• 1 other identifier: IPM 018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

Conditions

HIV Infections

Keywords

HIV-1 infection; HIV Seronegativity

Study Arms (3)

A

EXPERIMENTAL

Drug: dapivirine matrix intravaginal ring

B

EXPERIMENTAL

Drug: dapivirine reservoir intravaginal ring

C

PLACEBO COMPARATOR

Other: placebo intravaginal ring

Interventions

dapivirine reservoir intravaginal ring DRUG

a silicone elastomer reservoir ring containing 25mg of dapivirine

B

dapivirine matrix intravaginal ring DRUG

a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine

A

placebo intravaginal ring OTHER

a silicone elastomer intravaginal ring containing no dapivirine

C

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 18 and 35 years of age
• Willing and able to give written informed consent
• Available for all visits and consent to follow all procedures scheduled for the study
• Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
• Willing to abstain from sexual activity for the duration of the study
• Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment
• Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal
• Willing to refrain from use of vaginal products or objects for the duration of the study.

You may not qualify if:

• 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 compliance with protocol requirements;
• History of sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
• Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
• Currently or within one month of participating in any other clinical research study
• History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
• History of genital tract surgery within the last month
• Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas)
• Current vulvar or vaginal symptoms / abnormalities that could influence the study results
• History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months;
• Smoking more than 10 cigarettes per day

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (1)

Drug Research Unit Ghent (D.R.U.G.)

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Dr. Annalene Nel

  International Partnership for Microbicides (IPM)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: May 1, 2007
• Study Completion: August 1, 2007
• Last Updated: September 1, 2009

Record last verified: 2009-08

Locations

BE (1)