A Study of Lobucavir in Patients With AIDS

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.

Gender

ALL

Eligibility criteria

• • 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.