Cytomegalovirus Infections, HIV Infections
Conditions
Keywords
Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents
Brief summary
The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.
Detailed description
Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.
Interventions
DRUGLobucavir
Sponsors
Bristol-Myers Squibb
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Aerosolized pentamidine. * TMP / SMX. * Isoniazid. * Dapsone. * Fluconazole. * Ketoconazole. * Rifabutin. * Fluoxetine HCl. * Acetaminophen. * Antacids. * Metamucil. * Multivitamins. * Other drugs with approval from sponsor. Patients must have: * AIDS. * CD4 count \< 200 cells/mm3. * Cytomegalovirus ( CMV ) viruria and virosemenia. * No evidence of intraocular CMV.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness. * Inability to take oral medication. * Allergy to nucleoside analogs. * Diarrheal illness. * Poor venous access. * Positive test for drugs of abuse. * Any other condition that would render patient unsuitable for study. Patients with the following prior conditions are excluded: * History of pancreatitis. * Recent diarrheal illness. * History of weight loss. * Acute serious illness within 4 weeks prior to study entry. Prior Medication: Excluded within 4 weeks prior to study entry: * Erythropoietin. * Any agent with anti-CMV activity. * Other investigational agents. Prior Treatment: Excluded within 4 weeks prior to study entry: * Surgery. * Blood transfusion. Drug abuse.
Countries
United States
Outcome results
None listed