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

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ClinicalTrials.gov Identifier: NCT00530777
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : April 18, 2012
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
Royalty Research Fund - University of Washington
Puget Sound Partners for Global Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carey Farquhar, University of Washington

Tracking Information
First Submitted Date  ICMJE September 13, 2007
First Posted Date  ICMJE September 17, 2007
Results First Submitted Date  ICMJE March 22, 2012
Results First Posted Date  ICMJE April 18, 2012
Last Update Posted Date December 19, 2018
Study Start Date  ICMJE April 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation [ Time Frame: 4 weeks ]
Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
HIV-1 levels in plasma, genital tract, and breast milk [ Time Frame: 14 months ]
Change History Complete list of historical versions of study NCT00530777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
Vertical HIV-1 Transmission [ Time Frame: 1 year postpartum ]
Mother-to-child HIV transmission
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
  • Vertical HIV-1 Transmission [ Time Frame: 1 year ]
  • antenatal cervical HSV-2 levels [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
Official Title  ICMJE HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
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 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 (MTCT) transmission of HIV-1 infection.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Herpes Simplex
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2007)
148
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530777
Other Study ID Numbers  ICMJE 32462
07-7306-A01
R03HD057773 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carey Farquhar, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • Royalty Research Fund - University of Washington
  • Puget Sound Partners for Global Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Carey Farquhar, MD, MPH University of Washington
PRS Account University of Washington
Verification Date November 2018

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