Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081640
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2004-04-16
Brief Title:
Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 20005 Gel P
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PRO 2000 Gel is designed to be inserted into the vagina to protect women from getting HIV during sex So far PRO 2000 Gel has been tested for safety in 136 women from Europe and the United States This study will evaluate the safety and acceptability of PRO 2000 Gel when used by women in Pune India The study will also examine what Indian women and men think about using PRO 2000 Gel
Detailed Description:
Topical microbicides are designed to prevent the sexual transmission of HIV and other disease pathogens PRO 20005 Gel P or PRO 2000 is a vaginal microbicide that has been evaluated in Phase I safety trials in Europe and the US PRO 2000 Gel is easily manufactured highly stable and highly water-soluble The aqueous gel formulation contains a synthetic carbomer a lactic acidlactate buffer and preservatives In vitro PRO 2000 Gel has been shown to suppress infection by herpes viruses Chlamydia trachomatis Neisseria gonorrhoeae and a wide range of HIV-1 isolates This study will evaluate the safety and acceptability of PRO 2000 Gel in HIV uninfected women in Pune India The study is a precursor to a larger Phase IIIII study of PRO 2000 Gel
Participants in this study will be sexually active HIV uninfected women at either low or high risk for HIV infection Male partners of these women will also be enrolled in the study Participants will be asked to apply PRO 2000 Gel twice a day for 14 consecutive days between menses and to have vaginal intercourse with a single male partner using study-provided male condoms at least twice per week during the two weeks of PRO 2000 Gel use Participants will have a screening visit an enrollment visit and 3 study visits during the two weeks of PRO 2000 Gel use each visit will last about 1 hour Study visits will include a medical history gynecologic exam blood and urine tests and product acceptability questionnaires Colposcopy will be performed three times during the study Participants will also be asked to complete a Daily Study Record about product use and sexual activity and questionnaires about their willingness to use the product and their perceptions of the product
Four weeks after using PRO 2000 Gel participants will be asked to participate in a focus group to discuss product acceptability Participants male partners will also be asked to participate in focus groups about product use
Participants in this study will be sexually active HIV uninfected women at either low or high risk for HIV infection Male partners of these women will also be enrolled in the study Participants will be asked to apply PRO 2000 Gel twice a day for 14 consecutive days between menses and to have vaginal intercourse with a single male partner using study-provided male condoms at least twice per week during the two weeks of PRO 2000 Gel use Participants will have a screening visit an enrollment visit and 3 study visits during the two weeks of PRO 2000 Gel use each visit will last about 1 hour Study visits will include a medical history gynecologic exam blood and urine tests and product acceptability questionnaires Colposcopy will be performed three times during the study Participants will also be asked to complete a Daily Study Record about product use and sexual activity and questionnaires about their willingness to use the product and their perceptions of the product
Four weeks after using PRO 2000 Gel participants will be asked to participate in a focus group to discuss product acceptability Participants male partners will also be asked to participate in focus groups about product use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None