A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients

Completed · Phase 2

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026 concentrations and outcome/toxicity.

Key facts

Study ID

NCT00000863

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

45

Expected to finish

1998-07-01

Last updated by the study team

2021-10-28

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Any medications not listed as excluded will be permitted on study.
• [ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.]
• Patients must have:
• Documented HIV infection.
• Documented PCP.
• On a room air ABG, the PO2 value greater than or equal to 70 mm Hg and the (A-a) DO2 less than 35 mm Hg.
• Signed informed consent from parent or legal guardian for those patients less than 18 years of age.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Known hypersensitivity to quinolines.
• If patient is unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study.
• Concurrent Medication:
• Excluded:
• Any patient unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study (e.g., TMP/SMX, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine).
• Methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites).
• Patients with the following prior conditions or symptoms are excluded:
• History of G6PD deficiency, hemoglobin M abnormality, or NAD methemoglobin reductase deficiency.
• Prior Medication:
• Excluded:
• More than 24 hours receipt of anti-PCP treatment for the current episode of PCP. Receipt of prior PCP prophylaxis is permitted, as long as it is discontinued at study entry.

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• Queens Med. Ctr. — Honolulu, Hawaii, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Weiss Memorial Hosp. — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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