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A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vesnarinone
Sponsored by
Otsuka America Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections. Acyclovir for up to 14 days for acute herpes outbreaks. Patients must have: Documented HIV infection. CD4 count 50 - 300 cells/mm3. No active opportunistic infections. No fever, diarrhea, or Herpes zoster. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline. Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix). Concurrent Medication: Excluded: Antiretroviral agents, including ddI, ddC, AZT, and d4T. Immunosuppressive agents. Investigational HIV drugs/therapies including vaccines. Interferon or other immunomodulating agents. Corticosteroids (other than topical). Hematopoietins. Megestrol acetate. Agents known to cause neutropenia. Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. Cytotoxic chemotherapy. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: Prior history of cardiac disease. History of agranulocytosis or severe (grade 3 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function. Prior Medication: Excluded: AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry. Prior cytotoxic chemotherapy. Acyclovir for herpes prophylaxis within 48 hours prior to study entry. Prior Treatment: Excluded within 30 days prior to study entry: Erythropoietin, transfusion, or blood product use. Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).

Sites / Locations

  • AIDS Research Consortium of Atlanta

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00002337
Brief Title
A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
Official Title
A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
56 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vesnarinone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections. Acyclovir for up to 14 days for acute herpes outbreaks. Patients must have: Documented HIV infection. CD4 count 50 - 300 cells/mm3. No active opportunistic infections. No fever, diarrhea, or Herpes zoster. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline. Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix). Concurrent Medication: Excluded: Antiretroviral agents, including ddI, ddC, AZT, and d4T. Immunosuppressive agents. Investigational HIV drugs/therapies including vaccines. Interferon or other immunomodulating agents. Corticosteroids (other than topical). Hematopoietins. Megestrol acetate. Agents known to cause neutropenia. Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. Cytotoxic chemotherapy. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: Prior history of cardiac disease. History of agranulocytosis or severe (grade 3 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function. Prior Medication: Excluded: AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry. Prior cytotoxic chemotherapy. Acyclovir for herpes prophylaxis within 48 hours prior to study entry. Prior Treatment: Excluded within 30 days prior to study entry: Erythropoietin, transfusion, or blood product use. Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).
Facility Information:
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

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A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease

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