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A Study of Lobucavir in Patients With AIDS

Primary Purpose

Cytomegalovirus Infections, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lobucavir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mount Zion Med Ctr / UCSF
  • San Francisco Veterans Adm Med Cntr
  • Univ of Minnesota

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 1, 2007
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002352
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections, HIV Infections
Keywords
Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lobucavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mount Zion Med Ctr / UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco Veterans Adm Med Cntr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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