Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients
Lobucavir
Blood-Borne Infections+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
San Francisco Veterans Adm Med Cntr
San Francisco, United StatesUniv of Minnesota
Minneapolis, United States