A Study of Lobucavir in Patients With AIDS

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infections; Cytomegalovirus Infections

Treatments: Drug: Lobucavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002352

AI459-007

248A

Details and patient eligibility

About

The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.