NCT00002352CompletedNot Applicable
Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients
Bristol-Myers Squibb3 sites in 1 country30 target enrollmentStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 3
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •Aerosolized pentamidine.
- •TMP / SMX.
- •Isoniazid.
- •Fluconazole.
- •Ketoconazole.
- •Rifabutin.
- •Fluoxetine HCl.
- •Acetaminophen.
- •Antacids.
- •Metamucil.
- •Multivitamins.
- •Other drugs with approval from sponsor.
- •Patients must have:
- •CD4 count < 200 cells/mm
- •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:
- •Blood transfusion. Drug abuse.
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Unknown
Phase 2
Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 InfectionHIV/AIDSNCT04560569Frontier Biotechnologies Inc.20
Completed
Phase 3
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell TransplantationCancerNCT00045292Fred Hutchinson Cancer Center
Completed
Phase 2
Letermovir Treatment for Refractory or Resistant Cytomegalovirus InfectionCytomegalovirus InfectionsNCT03728426Amy C. Sherman, MD10
Active, not recruiting
Phase 2
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug ResistanceHIV-1-infectionNCT04150068Gilead Sciences72
Completed
Phase 2
Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With AlemtuzumabPeripheral T-Cell LymphomaPrimary Cutaneous T-Cell Non-Hodgkin LymphomaT-Cell Prolymphocytic LeukemiaSezary SyndromeB-Cell Prolymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT04312841Ohio State University Comprehensive Cancer Center6