A Study of Lobucavir in Patients With AIDS

HIV Infections Clinical Trial

Official title:

Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002352
• Other study ID #: 248A
• Secondary ID: AI459-007
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: October 1, 2007

Study information

• Verified date: October 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• HIV Infections
• Infection

Intervention

Drug:
• Lobucavir

Locations

Country	Name	City	State
United States	Univ of Minnesota	Minneapolis	Minnesota
United States	Mount Zion Med Ctr / UCSF	San Francisco	California
United States	San Francisco Veterans Adm Med Cntr	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm