Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076232
Status:
COMPLETED
Last Update Posted:
2010-12-30
First Post:
2004-01-15
Brief Title:
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive HIV Seronegative Individuals
Status:
COMPLETED
Status Verified Date:
2009-08
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:
Genital herpes HSV-2 is the most common cause of genital sores worldwide and the presence of genital sores is a significant risk factor for becoming infected with HIV This study will test the effectiveness of twice-daily dosing of acyclovir a commonly prescribed anti-herpes drug in preventing HIV infection in HSV-2 infected women who sleep with men WSM and men who sleep with men MSM
Study hypothesis Given that genital herpes is a significant risk factor to HIV acquisition twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk HSV-2 seropositive WSM and MSM
Study hypothesis Given that genital herpes is a significant risk factor to HIV acquisition twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk HSV-2 seropositive WSM and MSM
Detailed Description:
Many studies have shown that prior HSV-2 infection is associated with an increased risk for HIV infection Acyclovir is the most widely studied and clinically utilized antiviral for the suppression of HSV-2 infection This study will evaluate the efficacy of twice-daily dosing of acyclovir in preventing HIV infection in both WSM and MSM with genital herpes For this study WSM will be enrolled in Lusaka Zambia Harare Zimbabwe and Johannesburg South Africa MSM will be enrolled in Lima and Pucallpa Peru Seattle Washington USA New York City New York USA and San Francisco California USA
Participants will be enrolled for 12 months in this study and will be randomly assigned to one of two study arms The first arm will receive 400 mg acyclovir twice daily the second arm will receive placebo Follow-up visits will occur monthly Participants will be tested for STDs including HIV and syphilis at each visit and treated as necessary participants will also be given adherence and condom counseling risk behavior and sexual history questionnaires and genital symptoms questionnaires at all study visits Medical history will be assessed and participants will undergo blood work at Months 3 6 9 and 12
Participants will be enrolled for 12 months in this study and will be randomly assigned to one of two study arms The first arm will receive 400 mg acyclovir twice daily the second arm will receive placebo Follow-up visits will occur monthly Participants will be tested for STDs including HIV and syphilis at each visit and treated as necessary participants will also be given adherence and condom counseling risk behavior and sexual history questionnaires and genital symptoms questionnaires at all study visits Medical history will be assessed and participants will undergo blood work at Months 3 6 9 and 12
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 |
|---|---|---|---|
| 1R01AI052054 | NIH | None | None |
| 5U01AI047981-05 | NIH | None | None |
| DAIDS-ES ID 10066 | US NIH GrantContract | None | httpsreporternihgovquickSearch5U01AI047981-05 |