Completed
Safety and Tolerability of Vesnarinone in Advanced HIV Disease
Study Aim
This study aims to evaluate the safety and tolerability of Vesnarinone as a treatment in individuals with advanced HIV disease.
What is being tested
Vesnarinone
Drug
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+27 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
Fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. At least seven patients at a given dose level must have completed 4 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
56 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 DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections
Criteria
6 inclusion criteria required to participate
Acyclovir for up to 14 days for acute herpes outbreaks
CD4 count 50 - 300 cells/mm3
Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections
Documented HIV infection
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21 exclusion criteria prevent from participating
AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry
Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix)
Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents)
Acyclovir for herpes prophylaxis within 48 hours prior to study entry
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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
AIDS Research Consortium of Atlanta
Atlanta, United StatesOpen AIDS Research Consortium of Atlanta in Google MapsCompletedOne Study Center