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
NCT ID: NCT00001996
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Atovaquone
Pentamidine isethionate
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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East Bay AIDS Ctr
Berkeley, California, United States
Kaiser Foundation Hosp
Harbor City, California, United States
Cedars Sinai Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
UCI Med Ctr
Orange, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
Davies Med Ctr
San Francisco, California, United States
Dr Patrick Joseph
San Ramone, California, United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, United States
Massachusetts Gen Hosp
Boston, Massachusetts, United States
Boston City Hosp
Boston, Massachusetts, United States
Beth Israel Med Ctr
New York, New York, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, United States
Gathe, Joseph, M.D.
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Dohn M, Weinberg W, Rosenstock J, Follansbee S, Torres R, Caldwell P. Atovaquone vs. pentamidine for pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):372 (abstract no PO-B10-1421)
Other Identifiers
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05
Identifier Type: -
Identifier Source: secondary_id
053B
Identifier Type: -
Identifier Source: org_study_id