Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 who do not have PCP.
Escalating doses of WR 6026 will be studied in successive patient cohorts. Four patients will be randomized to active drug or placebo in a 3:1 ratio at each dose level until moderate toxicity is demonstrated. If one patient at a given dose level experiences WR 6026-related moderate or worse toxicity, the sample size for all subsequent dose levels will be doubled. If two or ...
Gender
ALL
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.
Trial Officials
Petty BG
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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