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

Sponsor
University of Washington
Study ID
NCT00530777
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • valacyclovir — DRUG
    500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
  • placebo — DRUG
    oral placebo twice daily from 34 weeks gestation to 1 year postpartum

Study Details

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).

Key Dates

Start date
Apr 30, 2008
Status verified
Nov 2018
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
148 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
  • Placebo Comparator: 2
    oral placebo twice daily from 34 weeks gestation to 1 year postpartum

Primary Outcome Measure

Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation [ Time Frame: 4 weeks ]

Related Studies