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CompletedNCT00332995Updated Sep 1, 2009

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

A Phase 1 interventional study of dapivirine (TMC120) vaginal ring in HIV Infections, sponsored by International Partnership for Microbicides, Inc.. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-01.

Sponsored by International Partnership for Microbicides, Inc. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV Seronegativity
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 13 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

International Partnership for Microbicides, Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 5 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
13 participants

Interventions

  • Drugdapivirine (TMC120) vaginal ring
06

What researchers measure

Primary outcomes

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

  2. 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).

07

Study locations

1 site
  • Drug Research Unit Gent
    Gent, 9000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00332995
Lead sponsor
International Partnership for Microbicides, Inc.
Collaborators
Tibotec Pharmaceutical Limited
First posted
Jun 2, 2006
Start date
Jul 2005
Completion
Aug 2005
Last update
Sep 1, 2009

Study contacts

Dr. Luc Van Bortel
principal investigator · University Ghent
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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