Completed
Vesnarinone Treatment for HIV-Infected Individuals with CD4+ Cell Number > 300 Cells/mm3
Study Aim
This phase 1 study aims to evaluate the safety and effectiveness of Vesnarinone treatment in HIV-infected individuals who have a CD4+ cell number greater than 300 cells/mm3.
What is being tested
Vesnarinone
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorOtsuka America Pharmaceutical
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.
Principal SponsorOtsuka America Pharmaceutical
Last updated: June 24, 2005
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
36 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 DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
4 inclusion criteria required to participate
Asymptomatic HIV infection
CD4 count > 300 cells/mm3
Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and herpes simplex
No prior AIDS-defining illness or current constitutional symptoms of HIV disease
18 exclusion criteria prevent from participating
AZT, ddI, and ddC within 14 days prior to study entry
Active illicit drug abuse
Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix
Antiretroviral agents, including ddI, ddC, and AZT
Show More Criteria
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 1 location
CompletedOne Study Center