Phase 4
N=34
Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV
Genital Herpes · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00527618 ↗Enrolled (actual)
34
Serious AEs
1.6%
Results posted
Jul 2012
Primary outcome: Primary: The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir. — 4.08; 3.68 log10 copies/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- valacyclovir (Drug); acyclovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir. |
4.08; 3.68 | <0.001 sig |
| PRIMARY The Genital HSV Shedding Rate While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir. |
8.2; 7.8 | 0.78 |
| SECONDARY The Effect of Valacyclovir 1 Gram Twice Daily Compared to Acyclovir 400 mg Twice Daily on the Percentage of Days With Genital Herpes Lesions. |
4.0; 1.0 | 0.16 |
| SECONDARY The Effect of Valacyclovir 1 g Twice Daily Compared With Acyclovir 400 mg Twice Daily on the Quantity of Genital HSV Detected During Shedding Episodes. |
3.0; 3.0 | 0.67 |
| SECONDARY Sub-Study: To Evaluate the Kinetics of Plasma HIV-1 Decline Over the First Three Days of High-dose Valacyclovir Administration. |
-0.20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Documented HIV-1 seropositive
- Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
- Detectable HIV-1 plasma viral load
- HSV-2 seropositive as determined by western blot
- Not intending to move out of the area for the duration of study participation
- Willing and able to provide independent written informed consent
- Willing and able to undergo clinical evaluations
- Willing and able to take study drug as directed
- Willing and able to adhere to follow-up schedule
Exclusion Criteria
- Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir
- Planned open label use of acyclovir, valacyclovir, or famciclovir
- History of evidence of CMV disease
- Known medical history of seizures
- Known renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl
- AST or ALT greater than 3 times upper limit of normal
- Hematocrit less than 30 %
- Neutropenia, defined as absolute neutrophil count less than 1000
- Thrombocytopenia, defined as platelet count less than 75,000
- History of thrombotic microangiopathy
- For women, pregnancy as confirmed by a urine pregnancy test
- Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
Data sourced from ClinicalTrials.gov (NCT00527618). 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.