Phase 2
N=148
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
HIV Infections · Herpes Simplex
Bottom Line
View on ClinicalTrials.gov: NCT00530777 ↗Enrolled (actual)
148
Serious AEs
2.0%
Results posted
Apr 2012
Primary outcome: Primary: Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation — -0.53; 0.03 log10 copies/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- valacyclovir (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation |
-0.53; 0.03 | — |
| SECONDARY Vertical HIV-1 Transmission |
6; 4 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00530777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.