Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

HIV Infections Clinical Trial

Official title:

Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700284
• Other study ID #: IPM 001, TMC120-C130
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2008
• Last updated: August 31, 2009
• Start date: October 2004
• Est. completion date: January 2005

Study information

• Verified date: August 2009
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female, 18-50 years, inclusive

• Willing and able to provide written informed consent

• HIV-uninfected and otherwise healthy

• Willing to abstain from sexual activity and use of vaginal products while participating in the trial

• Currently using oral contraceptives for pregnancy prevention

• Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial

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 compliance with protocol requirements.

• History of allergy to TMC120 or to the constituents of the vaginal ring.

• History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation

• 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 trial

• Current (during screening) diagnosis of any genital infection

• Current vulvar of vaginal symptoms

• Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• placebo vaginal ring
vaginal ring containing no TMC120 (dapivirine)
• TMC120 (dapivirine) vaginal ring
vaginal ring containing 120 mg TMC120 (dapivirine)

Locations

Country	Name	City	State
Belgium	Drug Research Unit, UZ Gent	Gent

Sponsors (2)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.	Tibotec Pharmaceutical Limited

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability of a vaginal ring containing TMC120 (dapivirine)		7 days	No
Primary	TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma		7 days	No