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
  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: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

ClinicalTrials.gov processed this record on August 01, 2014