HIV Infections Clinical Trial
Official title:
A Randomized, Double-Blind Trial of Valacyclovir Hydrochloride (BW 256U87) Prophylaxis for Opportunistic Cytomegalovirus End-Organ Disease in Patients With Advanced HIV Infection (< 100 CD4+ Lymphocytes)
PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the
prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with
CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral
acyclovir and low-dose oral acyclovir on survival.
SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug
administered concurrently with standard antiretroviral agents and other essential therapies
for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in
suppressing activation of other herpesviruses. To evaluate serologic and virologic risk
factors for the development of CMV disease, including assessment of HIV activation, and the
risk of developing drug-resistant CMV, HSV, and VZV.
Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in
patients with advanced HIV disease, although there is evidence that high doses of the drug
may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after
oral administration, has a higher absorption rate and may therefore provide inhibitory
activity against CMV.
Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in
patients with advanced HIV disease, although there is evidence that high doses of the drug
may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after
oral administration, has a higher absorption rate and may therefore provide inhibitory
activity against CMV.
Patients are randomized to receive BW 256U87 alone or acyclovir alone as control at either
high-dose or low-dose. The acyclovir controls will provide suppressive therapy for herpes
simplex infections and may affect survival.
;
Primary Purpose: Treatment
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