Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
International Partnership for Microbicides, Inc. |
---|---|
Information provided by: | International Partnership for Microbicides, Inc. |
ClinicalTrials.gov Identifier: | NCT00309205 |
Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.
Condition | Intervention | Phase |
---|---|---|
HIV Infections HIV-1 |
Drug: dapivirine (TMC120) vaginal gel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel Vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women. |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | IPM005B |
Study First Received: | March 30, 2006 |
Last Updated: | July 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00309205 |
Health Authority: | Belgium: Federal Public Service Health, Food Chain and Environment; Europe: European Medicines Agency |
HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |