HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Herpes Simplex
Intervention: valacyclovir (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Carey Farquhar, MD, MPH, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation
Secondary outcome: Vertical HIV-1 Transmission
Detailed description:
Each year over 500,000 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 CD4>200 cells/μl 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 transmission of HIV-1 infection.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- HIV-1 seropositive
- HSV-2 seropositive
- Plans to deliver in Nairobi
- Resides and plans to remain in Nairobi for 12 months postpartum
- 18 years of age or older
- CD4 count>250 cells/μl
Exclusion Criteria:
- indication for highly active antiretroviral therapy (e. g., WHO stage III or IV)
- hypersensitivity to valacyclovir or acyclovir
Locations and Contacts
Mathare North City Clinic, Nairobi, Kenya
Additional Information
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Starting date: April 2008
Last updated: March 22, 2012
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