Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00530777
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2007-09-13
Brief Title:
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
Status:
COMPLETED
Status Verified Date:
2018-11
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:
VIP
Brief Summary:
In this study we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 HIV-1 and herpes simplex virus type 2 HSV-2 with daily valacyclovir will reduce HIV-1 levels in plasma genital and breast milk and will decrease the risk of mother-to-child HIV-1 transmission MTCT
Detailed Description:
Each year over 500000 children become HIV-1-infected in sub-Saharan Africa after exposure to maternal virus in blood genital secretions and breast milk Identifying feasible safe and affordable interventions that prevent mother-to-child transmission remains a priority for HIV-1 prevention research Interventions to reduce breast milk HIV-1 transmission are lacking and most urgently needed
We propose a randomized clinical trial to determine whether incorporating HSV-2 suppression with valacyclovir into standard prevention of mother-to-child HIV-1 transmission regimens will reduce plasma cervical and breast milk HIV-1 RNA levels and risk of transmission among HIV-1-infected and HSV-2-seropositive women We plan to enroll a total of 148 HIV-1 and HSV-2 co-infected pregnant women with CD4200 cellsĪ¼l who seek antenatal care prior to 32 weeks gestation at a clinic in Nairobi Kenya Women will be randomized to receive either valacyclovir suppressive therapy or placebo at 34 weeks gestation and mother-infant pairs will be followed for 12 months postpartum Follow-up visits will be scheduled at 38 weeks gestation birth 2 6 10 and 14 weeks and 6 9 and 12 months postpartum Maternal blood genital and breast milk specimens obtained at follow-up visits will be used to determine the effect of valacyclovir suppressive therapy on plasma and breast milk HIV-1 RNA levels Infant filter paper specimens for HIV-1 DNA assays will be collected at birth 2 6 10 and 14 weeks and 6 9 and 12 months in order to compare the proportion of infants acquiring HIV-1 by 12 months in the two study arms and determine the timing of HIV-1 infection In addition we will monitor maternal and infant renal function in preparation for a larger randomized clinical trial in Africa The results of this study will help guide the design of a multi-site clinical trial with adequate power to determine the effect of HSV-2 suppression on vertical MTCT transmission of HIV-1 infection
We propose a randomized clinical trial to determine whether incorporating HSV-2 suppression with valacyclovir into standard prevention of mother-to-child HIV-1 transmission regimens will reduce plasma cervical and breast milk HIV-1 RNA levels and risk of transmission among HIV-1-infected and HSV-2-seropositive women We plan to enroll a total of 148 HIV-1 and HSV-2 co-infected pregnant women with CD4200 cellsĪ¼l who seek antenatal care prior to 32 weeks gestation at a clinic in Nairobi Kenya Women will be randomized to receive either valacyclovir suppressive therapy or placebo at 34 weeks gestation and mother-infant pairs will be followed for 12 months postpartum Follow-up visits will be scheduled at 38 weeks gestation birth 2 6 10 and 14 weeks and 6 9 and 12 months postpartum Maternal blood genital and breast milk specimens obtained at follow-up visits will be used to determine the effect of valacyclovir suppressive therapy on plasma and breast milk HIV-1 RNA levels Infant filter paper specimens for HIV-1 DNA assays will be collected at birth 2 6 10 and 14 weeks and 6 9 and 12 months in order to compare the proportion of infants acquiring HIV-1 by 12 months in the two study arms and determine the timing of HIV-1 infection In addition we will monitor maternal and infant renal function in preparation for a larger randomized clinical trial in Africa The results of this study will help guide the design of a multi-site clinical trial with adequate power to determine the effect of HSV-2 suppression on vertical MTCT transmission of HIV-1 infection
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 |
|---|---|---|---|
| 07-7306-A01 | None | None | None |
| R03HD057773 | NIH | None | httpsreporternihgovquickSearchR03HD057773 |