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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Herpes Simplex
Drug: valacyclovir
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vertical HIV-1 Transmission [ Time Frame: 1 year postpartum ] [ Designated as safety issue: Yes ]

Enrollment: 148
Study Start Date: April 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
Drug: valacyclovir
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
Other Name: Valtrex
Placebo Comparator: 2
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Drug: placebo
oral placebo twice daily from 34 weeks gestation to 1 year postpartum

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530777

Locations
Kenya
Mathare North City Clinic
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
Royalty Research Fund - University of Washington
Puget Sound Partners for Global Health
Investigators
Principal Investigator: Carey Farquhar, MD, MPH University of Washington
  More Information

Publications:
Whitehead S, Bollen L, Leelawiwat W, et al. Maternal HSV-2 Cervicovaginal Shedding Increases the Risk of Intra-partum HIV-1 Transmission. 14th Conference on Retroviruses and Opportunistic Infections. Los Angeles, 2007.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carey Farquhar, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00530777     History of Changes
Other Study ID Numbers: 32462-A, 07-7306-A01, R03HD057773
Study First Received: September 13, 2007
Results First Received: March 22, 2012
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board

Keywords provided by University of Washington:
Disease Transmission, Vertical
valacyclovir
Randomized Controlled Trials
HIV
herpes
Herpesvirus 2, Human
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014