Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

NCT00332995 | Completed Phase 1

• 1 other identifier: IPM008, TMC120-C131
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

Conditions

HIV Infections

Keywords

HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).

• Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120).

Interventions

dapivirine (TMC120) vaginal ring DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, age 18-50 years
• Willing and able to provide written informed consent
• HIV-uninfected and otherwise healthy
• Willing to abstain from sexual activity and from use of vaginal products while participating in the study
• Currently using oral contraceptives for pregnancy prevention
• Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study

You may not qualify if:

• History of allergy to TMC120 or to the constituents of the vaginal ring
• History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months
• History of genital tract surgery within the last month
• Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
• Currently or within one month of participating in any other clinical research study
• Current vulvar or vaginal symptoms / abnormalities that could influence the study results
• Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
• Current diagnosis of any genital infection
• Smoking more than 10 cigarettes / day

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (1)

Drug Research Unit Gent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Dapivirine; Contraceptive Devices, Female

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

Intervention Hierarchy (Ancestors)

Contraceptive Devices; Equipment and Supplies

Study Officials

• Dr. Luc Van Bortel

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: July 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 1, 2009

Record last verified: 2009-08

Locations

BE (1)