Completed

Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients

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What is being tested

Lobucavir

Drug
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: October 2, 2007
Sourced from a government-validated database.Claim as a partner

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

NCT00002352
Principal SponsorBristol-Myers Squibb
Last updated: October 2, 2007
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsHIV Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Mount Zion Med Ctr / UCSF

San Francisco, United StatesOpen Mount Zion Med Ctr / UCSF in Google Maps

San Francisco Veterans Adm Med Cntr

San Francisco, United States

Univ of Minnesota

Minneapolis, United States
Completed3 Study Centers