Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV
Summary
To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that high-dose valacyclovir will result in greater reduction in plasma HIV-1 and genital HSV reactivation.
Timeline
- Start
- 2007-12
- Primary completion
- 2011-03
- Completion
- 2011-03
Outcome
Mixed primary results
registry MEDIAN Acyclovir: 4.08 (1.17 to 5.33) log10 copies/mL NCT00527618 ↗
registry MEDIAN Valacyclovir: 3.68 (1.17 to 4.99) log10 copies/mL NCT00527618 ↗
registry analysis (superiority or other test); Acyclovir vs Valacyclovir; p <0.001; Slope -0.27 (95% CI -0.41 to -0.14); Mixed Models Analysis NCT00527618 ↗
registry analysis (superiority or other test); Acyclovir vs Valacyclovir; p = 0.78; Risk Ratio (RR) 0.95 (95% CI 0.66 to 1.37); Random effects poission regression NCT00527618 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acyclovir | Small molecule | 400 mg | Oral |
| Subject | Valacyclovir | Unknown | 1000 mg | Oral |