A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole

Launched by GLAXO WELLCOME · Aug 30, 2001

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have the following:
• • History of, or are currently experiencing, intolerance to TMP / SMX, or to another sulfonamide, which required discontinuation of therapy.
• • Pneumocystis carinii pneumonia (PCP).
• • Willing and able to give informed consent.
• • Exclusion Criteria
• Co-existing Condition:
• • Patients with the following conditions or symptoms are excluded.
• • Malabsorption disorder or vomiting that would, in the judgement of the investigator, potentially limit the retention and absorption of an oral therapy.
• • Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma, or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult.
• • Present occurrences of abnormal prolongation of QT interval on standard, 12 lead EKG.
• Concurrent Medication:
• Excluded:
• * Drugs with potential anti-pneumocystis effect (eg:
• • sulfonamides, dapsone, trimethoprim, other dihydrofolate reductase (DHFR) inhibitors, primaquine, clindamycin, sulfonylureas).
• • Ganciclovir.
• • Zidovudine.
• • Investigational agents including anti-retroviral agents (ddI, ddC, etc.). Patients receiving these drugs prior to entry must discontinue their use during the therapy phase (21 days) of the trial.
• • Corticosteroids (except replacement therapy) during the 21 day treatment period (Strata A and C Patients).
• * Class 1A antiarrhythmics (ie:
• • quinidine, procainamide, disopyramide).
• Patients with the following are excluded:
• • Judged by the investigator to be in impending respiratory failure.
• • Known intolerance to parenteral pentamidine isethionate, or therapeutic failure with same for treatment of current episode of PCP.
• • Significant psychosis or emotional disorder that, in the investigator's opinion, would preclude the patient from adhering to the protocol.
• • Inability or unwillingness to take medication orally or with food.
• • Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• • History, or present occurrences, of abnormal prolongation of QT interval on standard, 12 lead EKG.
• • Termination from FDA 053A due to toxicity.
• • For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion.
• Prior Medication:
• Excluded:
• • Treatment within 4 weeks of entry for a prior episode of PCP.
• • For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion.
• Required:
• • Adjuvant prednisone for patient enrolled in Strata B or D.