Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074425
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2003-12-11
Brief Title:
BufferGel and PRO 20005 Vaginal Gels to Prevent HIV Infection in Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase IIIIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 05 PRO 20005 Gel P for the Prevention of HIV Infection in Women
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The majority of HIV infected people worldwide became infected with the virus through heterosexual contact BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women from becoming infected with HIV during sexual intercourse with an HIV infected partner This study will test the safety and effectiveness of these gels
Detailed Description:
Accessible usable and effective vaginal microbicides could significantly decrease the spread of HIV Vaginal microbicides could be used with condoms to prevent HIV infection they could also be used in situations in which an individual is unable to negotiate condom use Vaginal microbicides are potentially bidirectional preventing both male-to-female and female-to-male HIV transmission This study will evaluate the safety and effectiveness of two vaginal microbicides BufferGel and PRO 20005 in preventing the transmission of HIV The study will also evaluate the effectiveness of these gels in preventing other common sexually transmitted infections STIs
BufferGel is a buffering agent designed to maintain normal vaginal acidity in the presence of ejaculate Studies have shown that HIV is inactivated below a pH of 4 to 58 Carbopol 974 the major nonaqueous component of BufferGel is commonly used as a gelling or tableting agent and has a well-documented safety record BufferGel has proven safe and well tolerated in Phase I studies PRO 20005 inhibits viral entry into susceptible cells PRO 20005 has also been evaluated in Phase I studies and was found to be safe and well tolerated
Participants in this study will be randomly assigned to receive one of four interventions BufferGel PRO 20005 placebo gel or no gel All participants will receive HIV risk reduction counseling condoms and diagnosis and treatment of sexually transmitted diseases Participants in the three gel arms will be given single-use prefilled applicators of gel and will be instructed to apply one dose of the product BufferGel PRO 20005 or placebo gel intravaginally up to 60 minutes before each vaginal intercourse while in the study
Participants will be enrolled for approximately 12 to 30 months depending on when they enter the study Participants will have two screening study visits and then monthly visits Monthly study visits may take place at a clinic the participants home or other community site Monthly visits will include a medical interview urine testing including pregnancy testing HIV and sexually transmitted infection risk reduction counseling and distribution of study supplies condoms and gel-filled applicators Blood collection will occur at selected monthly visits Four times a year participants will be seen in the clinic for a more structured medical interview pelvic exam and HIV testing At one of these visits participants at particular sites who are willing will be asked to complete a behavioral risk assessment At some visits vaginal fluid swabs will occur Participants at non-US study sites will be asked for permission for these swabs to be stored for further testing Assessment interviews will be both face to face and self-reporting
BufferGel is a buffering agent designed to maintain normal vaginal acidity in the presence of ejaculate Studies have shown that HIV is inactivated below a pH of 4 to 58 Carbopol 974 the major nonaqueous component of BufferGel is commonly used as a gelling or tableting agent and has a well-documented safety record BufferGel has proven safe and well tolerated in Phase I studies PRO 20005 inhibits viral entry into susceptible cells PRO 20005 has also been evaluated in Phase I studies and was found to be safe and well tolerated
Participants in this study will be randomly assigned to receive one of four interventions BufferGel PRO 20005 placebo gel or no gel All participants will receive HIV risk reduction counseling condoms and diagnosis and treatment of sexually transmitted diseases Participants in the three gel arms will be given single-use prefilled applicators of gel and will be instructed to apply one dose of the product BufferGel PRO 20005 or placebo gel intravaginally up to 60 minutes before each vaginal intercourse while in the study
Participants will be enrolled for approximately 12 to 30 months depending on when they enter the study Participants will have two screening study visits and then monthly visits Monthly study visits may take place at a clinic the participants home or other community site Monthly visits will include a medical interview urine testing including pregnancy testing HIV and sexually transmitted infection risk reduction counseling and distribution of study supplies condoms and gel-filled applicators Blood collection will occur at selected monthly visits Four times a year participants will be seen in the clinic for a more structured medical interview pelvic exam and HIV testing At one of these visits participants at particular sites who are willing will be asked to complete a behavioral risk assessment At some visits vaginal fluid swabs will occur Participants at non-US study sites will be asked for permission for these swabs to be stored for further testing Assessment interviews will be both face to face and self-reporting
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10065 | REGISTRY | DAIDS ES | None |