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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Procept |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00006207 |
Purpose
The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes irritation when used daily.
Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active. However, it was not determined what side effects to skin in the vaginal area there might be in sexually active women.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: PRO 2000 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Dose Comparison, Safety Study |
| Official Title: | A Phase I Multicenter Dose Escalation Safety and Acceptability Study of the Investigational Vaginal Microbicide Agent PRO 2000/5 Gel (P) |
| Estimated Enrollment: | 60 |
Vaginal microbicides are designed to inhibit the sexual transmission of HIV-1 and other disease pathogens. Two Phase I clinical trials were conducted to evaluate the safety and tolerance of the gel, PRO 2000/5, in sexually abstinent volunteers. Both demonstrated that multiple application of the gel was safe and well tolerated in healthy, sexually abstinent women but no clear association between the use of the gel and epithelial disruption was indicated. Because genital ulceration and inflammation may increase the risk of HIV infection, additional clinical evaluation of PRO 2000/5 gel is warranted, especially for study participants with active sexual behavior.
Participants apply PRO 2000/5 gel intravaginally either once or twice daily for 14 days. HIV-negative participants in sexually active cohorts (Cohorts A1-A4) are instructed to engage in vaginal intercourse at least twice a week. Participants in the HIV-positive cohort (Cohort B1) abstain from sexual intercourse for the dosing period. Researchers conduct physical exams to see if the gel is having any harmful effects on the woman's vulva, vagina, or cervix. Women and their male partners are questioned about gel usage.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers may be eligible for this study if they:
Exclusion Criteria
Volunteers will not be eligible for this study if they:
Contacts and Locations
More Information
| Study ID Numbers: | HIVNET 020 |
| Study First Received: | September 11, 2000 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006207 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV Seropositivity Dose-Response Relationship, Drug HIV Seronegativity Mucous Membrane Ulcer |
Vagina Anti-HIV Agents Sexual Abstinence Irritants PRO 2000 |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |