HIV Infections Clinical Trial
Official title:
An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons
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.
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 do not have genital herpes. This will help better
understand the effect that valacyclovir plays in the spread of HIV and the potential role
for HIV treatment in decreasing the HIV spread.
A total of 20 individuals who are HIV-1 seropositive and HSV-1/2 seronegative will be
recruited for the study. Participants must not be on antiretroviral therapy and must not be
planning to initiate HIV antiretroviral therapy during the study.
Participants will be asked to come to the clinic for a total of 16 visits over the course of
10 weeks. Participants will receive valacyclovir 1000 mg three times daily for 6 weeks.
During the first week, participants will return to the clinic for a total of 2 visits and
will provide plasma samples for baseline HIV-1 levels. During the second week, participants
will return to the clinic for a total 5 visits. At Visit 3, participants will be provided
the study medication. After drug initiation, participants will be asked to return to the
clinic within 6 hours and then again at Day 1, 2, and 3 post first dose. During weeks 3-8,
participants will be instructed to take valacyclovir and return to the clinic for one
follow-up visit each week to provide plasma samples for HIV-1 detection.
Participants will be asked to return to the clinic for 3 follow-up visits after study drug
discontinuation to provide plasma samples for HIV-1 detection.
Participants will be asked to complete a daily symptom and medication diary. All supplies
and study medical will be provided.
This is an outpatient study.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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