A Study of Lobucavir in Patients With AIDS

NCT ID: NCT00002352

Last Updated: 2007-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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

Conditions

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Cytomegalovirus Infections HIV Infections

Keywords

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Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Lobucavir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Mount Zion Med Ctr / UCSF

San Francisco, California, United States

Site Status

San Francisco Veterans Adm Med Cntr

San Francisco, California, United States

Site Status

Univ of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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AI459-007

Identifier Type: -

Identifier Source: secondary_id

248A

Identifier Type: -

Identifier Source: org_study_id