The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS
Status:
Completed
Trial end date:
1993-02-01
Target enrollment:
Participant gender:
Summary
To find oral doses of FIAC (a pyrimidine nucleoside analog) that are effective in treating
cytomegalovirus (CMV) viremia in HIV-infected immunocompromised patients; to determine
tolerance and safety of FIAC in this patient population; and to determine pharmacokinetics
following multiple doses of FIAC. (An example of another nucleoside analog effective against
retroviruses such as HIV is zidovudine (AZT).) CMV infection is a medically significant
opportunistic disease in patients with HIV-related infection. The purine nucleoside
ganciclovir has been used to treat AIDS patients with CMV disease. Although ganciclovir is
useful in treating CMV disease, such treatment is frequently complicated by hematologic
(blood) toxicity. Also, treatment is difficult because it requires daily intravenous dosing.
Test tube studies show that FIAC and its primary breakdown product FIAU are highly and
specifically active against several viruses including CMV. A single-dose, pharmacokinetic
(blood level) study showed that FIAC, when taken orally, is readily absorbed into the
bloodstream, and most of it is converted to FIAU.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)