HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
NCT ID: NCT00530777
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2008-04-30
2010-08-31
Brief Summary
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Detailed Description
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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 (MTCT) transmission of HIV-1 infection.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
valacyclovir
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
2
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
placebo
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Interventions
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valacyclovir
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
placebo
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* hypersensitivity to valacyclovir or acyclovir
18 Years
FEMALE
No
Sponsors
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Royalty Research Fund - University of Washington
OTHER
Puget Sound Partners for Global Health
UNKNOWN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Washington
OTHER
Responsible Party
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Carey Farquhar
Associate Professor
Principal Investigators
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Carey Farquhar, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Mathare North City Clinic
Nairobi, , Kenya
Countries
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References
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Other Identifiers
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07-7306-A01
Identifier Type: -
Identifier Source: secondary_id
32462
Identifier Type: -
Identifier Source: org_study_id