NCT00002131

Brief Summary

To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Sarcoma, KaposiHIV Infections

Keywords

Sarcoma, KaposiAcquired Immunodeficiency SyndromeAntiviral Agentsvesnarinone

Interventions

VesnarinoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
  • Acyclovir as acute treatment for herpes outbreaks.
  • Concurrent Treatment:
  • Allowed:
  • Limited electron-beam radiation therapy to non-marker lesions for treatment of Kaposi's sarcoma.
  • Patients must have:
  • Documented HIV infection.
  • Kaposi's sarcoma.
  • No current constitutional signs of HIV disease or AIDS-defining conditions other than Kaposi's sarcoma.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active malignancy other than Kaposi's sarcoma, cutaneous basal cell carcinoma, or in situ carcinoma of the cervix.
  • Current significant cardiac disease or anomaly (including prolonged QTC on EKG).
  • Abnormal cardio-thoracic ratio on chest x-ray.
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral agents, including ddI, ddC, AZT, and d4T.
  • Immunosuppressive agents.
  • Investigational HIV drugs/therapies including vaccines (except those on treatment IND for approved indications).
  • Other anti-Kaposi's sarcoma/HIV drugs.
  • Corticosteroids (other than topical).
  • Biologic response modifiers.
  • Megestrol acetate.
  • Agents known to cause neutropenia.
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA School of Medicine

Los Angeles, California, 900121973, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Petit RG, Miles S, Magpantay L, Mitsuyasu R. Vesnarinone inhibits AIDS-KS cells in culture. Int Conf AIDS. 1994 Aug 7-12;10(1):169 (abstract no PB0104)

    BACKGROUND

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

vesnarinone

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations

US(2)