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A Study of Lobucavir in Patients With AIDS

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00002352
  Purpose

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


Condition Intervention
Cytomegalovirus Infections
HIV Infections
Drug: Lobucavir

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

ChemIDplus related topics:   Lobucavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Safety Study
Official Title:   Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:   30

Detailed Description:

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002352

Locations
United States, California
Mount Zion Med Ctr / UCSF    
      San Francisco, California, United States, 94115
San Francisco Veterans Adm Med Cntr    
      San Francisco, California, United States, 94121
United States, Minnesota
Univ of Minnesota    
      Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators
Bristol-Myers Squibb
  More Information


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
 

Study ID Numbers:   248A, AI459-007
First Received:   November 2, 1999
Last Updated:   October 1, 2007
ClinicalTrials.gov Identifier:   NCT00002352
Health Authority:   United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Cytomegalovirus Infections  
Acquired Immunodeficiency Syndrome  
Antiviral Agents  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Lobucavir
Acquired Immunodeficiency Syndrome
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections
Cytomegalic inclusion disease

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on September 16, 2008




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