Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2.

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

Details

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

Criteria

Inclusion Criteria:

• HIV-1 seropositive

• Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period

• CD4 cell count >250 cell/µL

• Not otherwise eligible for antiretroviral therapy according to Uganda national guidelines

• Detectable HIV-1 plasma viral load

• HSV-2 seropositive

• Not intending to move out of the area for the duration of study participation.

• Able to participate in the study at the Partners in Prevention site in Thika, Kenya

Exclusion Criteria:

• Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.

• Planned use of acyclovir, valacyclovir, or famciclovir

• Use of ganciclovir, foscarnet, or cidofovir

• Known medical history of seizures

• Serum creatinine >1.5 mg/dL

• AST or ALT >3 times upper limit of normal

• Hematocrit <30 %

• Absolute neutrophil count <1000

• Platelet count <75,000

• History of thrombotic microangiopathy

• Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study

• Participation in another HIV therapeutics trial

• For women, pregnancy as confirmed by a urine pregnancy test