A Study of Lobucavir in Patients With AIDS

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Lobucavir

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.