Status:
COMPLETED
A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
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 outcom...
Detailed Description
All patients will receive an initial loading dose of WR 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of WR 6026 taken in a fasting state for 3 weeks.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 1998
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00000863
End Date
July 1 1998
Last Update
October 28 2021
Active Locations (12)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
Queens Med. Ctr.
Honolulu, Hawaii, United States, 96816
3
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
4
Northwestern University CRS
Chicago, Illinois, United States, 60611