The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS
Condition: Cytomegalovirus Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.

      Patients are treated as outpatients if general health permits. This is continued for up to 90
      days or until failure on basis of efficacy, tolerance, or toxicity. The dose escalation
      between groups of patients uses the formula n + 0.7n. Entry of new patients at the next
      higher dose is based on results of antiviral, tolerance, and safety data for the prior cohort
      when they have received at least 14 days of therapy. Consecutively qualifying patients are
      enrolled for each dose group and not based on either disease severity or expected tolerance.
      Although not formally randomized due to the sequential nature of the study and serious
      medical condition of the patients, every attempt to avoid bias in assigning a patient to a
      dose is made. Patients are advised to avoid heavy exercise within 24 hours of any laboratory
      tests.
    

Intervention name(s): Fiacitabine
Intervention type(s): Drug
Intervention MeSH terms: Fiacitabine
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Pyrimidine Nucleosides; Drug Evaluation; fiacitabine; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Antiviral Agents