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HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
This study is ongoing, but not recruiting participants.
Study NCT00530777   Information provided by University of Washington
First Received: September 13, 2007   Last Updated: August 20, 2009   History of Changes

September 13, 2007
August 20, 2009
April 2008
September 2009   (final data collection date for primary outcome measure)
HIV-1 levels in plasma, genital tract, and breast milk [ Time Frame: 14 months ] [ Designated as safety issue: No ]
HIV-1 levels in plasma, genital tract, and breast milk [ Time Frame: 14 months ]
Complete list of historical versions of study NCT00530777 on ClinicalTrials.gov Archive Site
  • Vertical HIV-1 transmission [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • antenatal cervical HSV-2 levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Maternal Creatinine and infant ALT and creatinine levels [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Vertical HIV-1 transmission [ Time Frame: 1 year ]
  • antenatal cervical HSV-2 levels [ Time Frame: 4 weeks ]
 
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

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.

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.
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • HIV Infections
  • Herpes Simplex
  • Drug: valacyclovir
  • Drug: placebo
  • Experimental: 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
  • Placebo Comparator: oral placebo twice daily from 34 weeks gestation to 1 year postpartum

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
148
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00530777
Dr. Carey Farquhar, Assistant Professor, University of Washington
32462-A, 07-7306-A01
University of Washington
  • Royalty Research Fund - University of Washington
  • Puget Sound Partners for Global Health
  • National Institutes of Health (NIH)
Principal Investigator: Carey Farquhar, MD, MPH University of Washington
University of Washington
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP




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