An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at the effect of daily herpes medication, valacyclovir, on HIV levels in the blood in persons who are HIV positive and do not have oral or genital herpes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• > 18 years old

• HIV-1 seropositive

• CD4 count>250 cell/mm3

• Detectable HIV-1 plasma viral load

• HSV-1 & 2 seronegative.

• Not on HIV antiretroviral therapy or planning to initiate antiretroviral therapy during the study period.

• Not intending to move out of the area for 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.

• Use of ganciclovir, foscarnet, or cidofovir

• History of evidence of CMV disease

• Known medical history of seizures

• Known renal insufficiency, defined as serum creatine >1.5 mg/dl

• AST or ALT >3times upper limit of normal

• Hematocrit <30%

• Neutropenia, defined as absolute neutrophil count <1000

• Thrombocytopenia, defined as platelet count <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