Completed

Vesnarinone Treatment for AIDS-Related Kaposi's Sarcoma

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What is being tested

Vesnarinone

Drug
Who is being recruted

Blood-Borne Infections+21

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorOtsuka America Pharmaceutical
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Twenty-eight patients (14 per cohort) receive daily vesnarinone at one of two doses. At least seven patients at the lower dose must have completed 2 weeks of therapy before subsequent patients are entered at the higher dose. Patients who successfully complete 16 weeks of treatment may receive maintenance therapy for the duration of the study (approximately 12-18 months).

NCT00002131
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

28 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 DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissueRetroviridae InfectionsRNA Virus InfectionsSarcomaSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsNeoplasms, Connective and Soft TissueAcquired Immunodeficiency SyndromeSarcoma, KaposiHIV Infections

Criteria

6 inclusion criteria required to participate
Patients must have Kaposi's sarcoma
Patients must have documented HIV infection
Patients must have no current constitutional signs of HIV disease or AIDS-defining conditions other than Kaposi's sarcoma
Acyclovir as acute treatment for herpes outbreaks is allowed
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23 exclusion criteria prevent from participating
Patients with abnormal cardio-thoracic ratio on chest x-ray are excluded
Patients with active illicit drug abuse (specifically cocaine, amyl nitrate, heroin, or other cardioactive agents) within 30 days prior to study entry are excluded
Patients with active malignancy other than Kaposi's sarcoma, cutaneous basal cell carcinoma, or in situ carcinoma of the cervix are excluded
Patients with current significant cardiac disease or anomaly (including prolonged QTC on EKG) 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

UCLA School of Medicine

Los Angeles, United StatesOpen UCLA School of Medicine in Google Maps

Northwestern Univ Med School

Chicago, United States
Completed2 Study Centers