Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000926
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of Nonoxynol-9 N-9 and HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase III Nonoxynol-9 and HIV Infection
Status:
COMPLETED
Status Verified Date:
2021-10
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 purpose of this study is to see if nonoxynol-9 N-9 gel used in the vagina can prevent the spread of HIV
Most of the people with HIV in the world today live in southern Africa Because this population is not likely to use condoms an HIV-prevention method that women can control is needed N-9 used in the vagina may help prevent the spread of HIV and other sexually transmitted diseases
Most of the people with HIV in the world today live in southern Africa Because this population is not likely to use condoms an HIV-prevention method that women can control is needed N-9 used in the vagina may help prevent the spread of HIV and other sexually transmitted diseases
Detailed Description:
Intravaginal application of N-9 may help protect women from HIV and other STD infection Low rates of condom use in sub-Saharan African populations which constitute the majority of HIV infections dictate the need for prophylactic methods women can control
This trial will be conducted in Zimbabwe and Malawi The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo Following the pilot study and prior to screening for enrollment in the Phase III trial potential volunteers will participate in a 2-month behavioral counseling program that will encourage the use of condoms Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months Participants have a follow-up evaluation once a month a pelvic exam and blood tests are performed every third month
This trial will be conducted in Zimbabwe and Malawi The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo Following the pilot study and prior to screening for enrollment in the Phase III trial potential volunteers will participate in a 2-month behavioral counseling program that will encourage the use of condoms Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months Participants have a follow-up evaluation once a month a pelvic exam and blood tests are performed every third month
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HIVNET 016 | Registry Identifier | DAIDS ES | None |
| 11712 | REGISTRY | None | None |