Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2
(HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and
HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and
may make HIV progress faster. The study will evaluate:
"Whether people who take acyclovir can avoid antiretroviral treatment until later in their
lives
"Whether people who take acyclovir get fewer genital ulcers
"How well people are able to take acyclovir and any side effects they experience from it
"Differences in the amount of HIV virus in the blood of patients who are and are not taking
acyclovir, and how HIV/AIDS is different in these patients.
People 18 years of age and older living in the Rakai district of Uganda who are infected with
both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are
randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no
active ingredient) daily for 2 years. During this time, they visit the clinic once a month
for a routine physical examination. Patients who develop genital ulcers or complications of
HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to
begin antiretroviral therapy, are treated accordingly.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Johns Hopkins University Translational Genomics Research Institute University of Washington