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CompletedNCT00700284Updated Sep 1, 2009

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

A Phase 1 interventional study of placebo vaginal ring and TMC120 (dapivirine) 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
12
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV-I
  • Reverse transcriptase inhibitors
  • 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 12 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, 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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Placebo comparator
    A

    Drug: placebo vaginal ring

  • Experimental
    B

    Drug: TMC120 (dapivirine) vaginal ring

Interventions

  • Drugplacebo vaginal ring

    vaginal ring containing no TMC120 (dapivirine)

  • DrugTMC120 (dapivirine) vaginal ring

    vaginal ring containing 120 mg TMC120 (dapivirine)

06

What researchers measure

Primary outcomes

  1. safety and tolerability of a vaginal ring containing TMC120 (dapivirine)

    Time frame: 7 days

  2. TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma

    Time frame: 7 days

07

Study locations

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

References and documents

09

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 ↗
10

Registry details

Key details

Study ID
NCT00700284
Lead sponsor
International Partnership for Microbicides, Inc.
Collaborators
Tibotec Pharmaceutical Limited
First posted
Jun 18, 2008
Start date
Oct 2004
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Sep 1, 2009

Study contacts

Dr Luc Van Bortel
principal investigator · Drug Research Unit, UZ Gent

Oversight

Data monitoring committee
No
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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