A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
Completed · Phase 1
Conditions studied: HIV Infections
In brief
To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
Key facts
- Study ID
- NCT00002337
- Run by
- Otsuka America Pharmaceutical
- People needed
- 56
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.