Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371592
Status:
COMPLETED
Last Update Posted:
2013-09-23
First Post:
2006-09-01
Brief Title:
Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 HSV-2
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Double-blind Placebo-controlled Trial of Acyclovir for the Suppression of Human Immunodeficiency Virus Type 1 HIV-1 Viral Load and Mucosal Shedding in HIV-1 Herpes Simplex Virus Type 2 HSV-2 Co-Infected Women
Status:
COMPLETED
Status Verified Date:
2013-09
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 determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 HSV-2 who are starting HIV treatment for the first time
Detailed Description:
Women coinfected with HIV and HSV-2 experience more genital herpes outbreaks than women infected only with HSV-2 Frequent or recurrent herpes outbreaks in women infected with HIV can lead to an increase in both HIV plasma viral load and cervical shedding of HIV Some preliminary clinical studies have shown that acyclovir treatment for the management of HSV-2 infection can help lower HIV viral load in patients coinfected with both HIV and HSV-2 Supplementing highly active antiretroviral therapy HAART with HSV-2 treatment in patients coinfected with both HIV and HSV-2 may help strengthen the effects of HAART by more effectively lowering plasma and genital HIV viral load This study will determine whether HSV-2 treatment with acyclovir is effective in controlling HIV plasma viral load and cervical shedding of HIV in women starting on HAART as per Peruvian guidelines
This study will last 24 weeks Participants will be randomly assigned into one of two groups Group 1 participants will receive twice-daily 800 mg of acyclovir for 24 weeks Group 2 participants will receive twice-daily placebo for 24 weeks Both groups will receive HAART from the Peruvian Ministry of Health There will be 15 visits during this study Medical history a physical exam blood collection family planning counseling and cervical vaginal and vulvar swab collection will begin prior to study entry and will occur at all study visits
This study will last 24 weeks Participants will be randomly assigned into one of two groups Group 1 participants will receive twice-daily 800 mg of acyclovir for 24 weeks Group 2 participants will receive twice-daily placebo for 24 weeks Both groups will receive HAART from the Peruvian Ministry of Health There will be 15 visits during this study Medical history a physical exam blood collection family planning counseling and cervical vaginal and vulvar swab collection will begin prior to study entry and will occur at all study visits
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 |
|---|---|---|---|
| 10413 | REGISTRY | DAIDS ES | None |
| CIPRA Peru Project 1 | None | None | None |