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A Study of Lobucavir in Patients With AIDS
This study has been completed.
First Received: November 2, 1999   Last Updated: October 1, 2007   History of Changes
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

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

Resource links provided by NLM:


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

Additional Information:
No publications provided

Study ID Numbers: 248A, AI459-007
Study First Received: November 2, 1999
Last Updated: October 1, 2007
ClinicalTrials.gov Identifier: NCT00002352     History of Changes
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:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Lobucavir
Acquired Immunodeficiency Syndrome
Cytomegalovirus
Antiviral Agents
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Cytomegalic Inclusion Disease
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Lobucavir
Molecular Mechanisms of Pharmacological Action
Infection
Anti-Retroviral Agents
Therapeutic Uses
Cytomegalovirus Infections
Retroviridae Infections
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 02, 2009