Status:
COMPLETED
Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the maximum tolerated dose (MTD) of WR 6026 in HIV-infected patients. To determine whether any unexpected toxicities are caused by WR 6026 in HIV-infected patients. To determine whether t...
Detailed Description
In recent animal studies, WR 6026 demonstrated inhibitory activity against Pneumocystis carinii pneumonia (PCP). This study will assess the safety and tolerance of this drug in HIV-infected patients w...
Eligibility Criteria
Inclusion Criteria
Patients must have:
- HIV antibody positive.
- CD4 cell counts less than 500/mm3.
- Adequate general health.
- No significant deterioration in performance status within the past month.
- Prior treatment with a stable regimen of antiretroviral medication for at least 4 weeks prior to study.
Prior Medication:
Required:
- Stable regimen of antiretroviral medication for at least 4 weeks prior to study entry.
Allowed:
- Aerosolized pentamidine for PCP prophylaxis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Intercurrent infection.
- Clinically significant abnormality on EKG.
- Known hypersensitivity to quinolines.
- Known hemoglobin M abnormality.
- Known NADH methemoglobin reductase deficiency.
- Positive test for G6PD deficiency.
- Fever.
Prior Medication:
Excluded:
- Other systemic medication (other than AZT, ddC, ddI, methadone, acyclovir, and NSAIDs) within 3 days prior to study entry.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1993
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00000740
End Date
September 1 1993
Last Update
November 4 2021
Active Locations (2)
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1
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
2
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287