Completed
Long-Term Safety of Vesnarinone in HIV-Infected Individuals
What is being tested
Vesnarinone
Drug
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+17 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorOtsuka America Pharmaceutical
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients who have completed a limited duration study (less than 12 months of continuous treatment) of vesnarinone on protocols FDA 234A or FDA 234B and who have no current signs or symptoms of AIDS-defining illnesses may roll over to this study and continue receiving their regimen of vesnarinone for 12 months beyond their original participation.
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.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 DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections
Criteria
3 inclusion criteria required to participate
Acyclovir for acute treatment of herpes is allowed
Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria is allowed
Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B
14 exclusion criteria prevent from participating
Active illicit drug abuse is excluded
Acyclovir as prophylaxis for herpes within 48 hours prior to study entry is excluded
Agents known to cause neutropenia are excluded
Antiretroviral agents, including ddI, ddC, AZT, and d4T are excluded
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 2 locations
AIDS Research Consortium of Atlanta
Atlanta, United StatesCompleted2 Study Centers