Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: GlaxoSmithKline
• Treatments: Acyclovir; Valacyclovir

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