Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00332995 |
Recruitment Status
:
Completed
First Posted
: June 2, 2006
Last Update Posted
: September 1, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: dapivirine (TMC120) vaginal ring | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring. |
Study Start Date : | July 2005 |
Study Completion Date : | August 2005 |

- 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).

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332995
Belgium | |
Drug Research Unit Gent | |
Gent, Belgium, 9000 |
Principal Investigator: | Dr. Luc Van Bortel | University of Ghent |
Responsible Party: | Zeda Rosenberg ScD, International Partnership for Microbicides |
ClinicalTrials.gov Identifier: | NCT00332995 History of Changes |
Other Study ID Numbers: |
IPM008, TMC120-C131 |
First Posted: | June 2, 2006 Key Record Dates |
Last Update Posted: | September 1, 2009 |
Last Verified: | August 2009 |
Keywords provided by International Partnership for Microbicides, Inc.:
HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |