Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00530777 | HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding | PHASE2 | COMPLETED | 148 | — | — | Apr 1, 2008 | Aug 1, 2010 | Dec 19, 2018 | 1 | Kenya |
Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum |
| 2 | PLACEBO_COMPARATOR | oral placebo twice daily from 34 weeks gestation to 1 year postpartum |
| Name | Type | Description |
|---|---|---|
| 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 |
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 s...