HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding (VIP)

This study has been completed.
Sponsor:
Collaborators:
Royalty Research Fund - University of Washington
Puget Sound Partners for Global Health
Information provided by (Responsible Party):
Carey Farquhar, University of Washington
ClinicalTrials.gov Identifier:
NCT00530777
First received: September 13, 2007
Last updated: March 22, 2012
Last verified: March 2012

September 13, 2007
March 22, 2012
April 2008
August 2010   (final data collection date for primary outcome measure)
Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation [ Time Frame: 4 weeks ] [ 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 postpartum ] [ Designated as safety issue: Yes ]
  • Vertical HIV-1 transmission [ Time Frame: 1 year ]
  • antenatal cervical HSV-2 levels [ Time Frame: 4 weeks ]
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Herpes Simplex
  • Drug: valacyclovir
    500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
    Other Name: Valtrex
  • Drug: placebo
    oral placebo twice daily from 34 weeks gestation to 1 year postpartum
  • Experimental: 1
    500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
    Intervention: Drug: valacyclovir
  • Placebo Comparator: 2
    oral placebo twice daily from 34 weeks gestation to 1 year postpartum
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
August 2010
August 2010   (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
32462-A, 07-7306-A01, R03HD057773
Yes
Carey Farquhar, University of Washington
University of Washington
  • Royalty Research Fund - University of Washington
  • Puget Sound Partners for Global Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Carey Farquhar, MD, MPH University of Washington
University of Washington
March 2012

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