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A Study of Lobucavir in Patients With AIDS

This study has been completed.
Study NCT00002352.   Last updated on October 1, 2007.   Information provided by Bristol-Myers Squibb

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Descriptive Information Fields
Brief Title  A Study of Lobucavir in Patients With AIDS
Official Title  Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients
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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Dose Comparison, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cytomegalovirus Infections
HIV Infections
Intervention  Drug: Lobucavir
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  30
Start Date 
Completion Date
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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002352
Organization ID 248A
Secondary IDs †† AI459-007
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Information Provided By Bristol-Myers Squibb
Verification Date October 2007
First Received Date  November 2, 1999
Last Updated Date October 1, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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