Human Herpesvirus 8 Clinical Trial
Official title:
Suppression of Oral Shedding of Human Herpesvirus 8 (HHV-8) With Valganciclovir
The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth.
The purpose of the study is to use valganciclovir to define the role of antiviral therapy in
suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that
valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in
the mouth. Such reduction will serve to confirm that the mouth is the site of active HHV-8
replication. If valganciclovir is found to be effective, the findings from this proposal
would serve as the basis for a clinical trial with valganciclovir for prevention of Kaposi's
Sarcoma (KS) in high-risk HHV-8 seropositive persons.
After informed consent, all subjects will undergo medical history, physical examination and
screening laboratory examination. Eligible patients will return to clinic for randomization
to receiver either valganciclovir 900 mg qd or placebo. Participants will receive a diary
for noting adverse events and concurrent medications. The clinician will instruct the
participants on collection of mouth swabs and provide Dacron swabs, vials with PCR media and
pre-printed labels. Subjects will be asked to obtain a swab of oral mucosa every morning.
Clinic visits every other week will serve to review interim medical history and diaries for
adverse events, collect PCR swabs, dispense additional medication and draw safety labs. The
study uses a double-blind, randomized placebo design. Therefore, participants will not know
whether they will be taking a placebo or active medication at any time during the study. Due
to the crossover study design, however, all participants will receive the same amount of
placebo and study drug over the duration.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00380770 -
HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT
|
Phase 4 |