A Study of Lobucavir in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002352
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007

November 2, 1999
October 1, 2007
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Complete list of historical versions of study NCT00002352 on ClinicalTrials.gov Archive Site
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A Study of Lobucavir in Patients With AIDS
Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients

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

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

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Cytomegalovirus Infections
  • HIV Infections
Drug: Lobucavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002352
248A, AI459-007
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Bristol-Myers Squibb
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Bristol-Myers Squibb
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP