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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Puget Sound Partners for Global Health; Royalty Research Fund - University of Washington
• Treatments: Acyclovir; Valacyclovir

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