- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002352
A Study of Lobucavir in Patients With AIDS
October 1, 2007 updated by: Bristol-Myers Squibb
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up.
Weekly clinic visits are required.
Study Type
Interventional
Enrollment
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- Mount Zion Med Ctr / UCSF
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San Francisco, California, United States, 94121
- San Francisco Veterans Adm Med Cntr
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Univ of Minnesota
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
October 2, 2007
Last Update Submitted That Met QC Criteria
October 1, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Disease Attributes
- DNA Virus Infections
- Herpesviridae Infections
- Infections
- Communicable Diseases
- Cytomegalovirus Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Lobucavir
Other Study ID Numbers
- 248A
- AI459-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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