HIV Infection Clinical Trial
Official title:
A Randomized, Open-label, Crossover Trial of the Effect of Dosing of Daily HSV-2 Suppressive Therapy on HSV Reactivation and Plasma HIV-1 Levels Among HIV-1/ HSV-2 Co-infected Persons
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.
We propose to conduct a randomized, open-label, cross-over study of 38 individuals who are
HIV-1 seropositive and HSV-2 seropositive. Both men and women will be recruited for the
study. Participants must not be on antiretroviral therapy and must not be planning to
initiate antiretroviral therapy during the anticipated study period. Participants will be
randomized 1:1 to receive acyclovir 400 mg twice daily or valacyclovir 1000 mg twice daily.
After 12 weeks on the initial treatment, each participant will be crossed over to the
alternative treatment arm for 12 weeks. The treatment periods will be separated by a 2-week
washout period. During the first four weeks of each treatment period (i.e. weeks 1-4 and
weeks 15-18), participants will provide self-collected genital swabs daily for HSV DNA
quantification. Each week during the entire study period plasma samples will be collected
from participants for HIV-1 RNA quantification.
Open-label acyclovir and valacyclovir will be used for this trial, as the primary outcome
measures (genital HSV and plasma HIV-1) are unlikely to be influenced by knowledge of
treatment assignment. However, laboratory staff performing plasma HIV-1 and genital HSV
measurements will not be aware of treatment assignment.
Optional Sub-Study A: Sub-study A will be offered to study participants. The purpose of
sub-study A is to measure the effect of valacyclovir twice daily on plasma HIV-1 replication.
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