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
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention: Atovaquone (Drug); Pentamidine isethionate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Glaxo Wellcome
Summary
To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the
treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are
intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the
incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy
of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the
same population.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
East Bay AIDS Ctr, Berkeley, California 94704, United States
Kaiser Foundation Hosp, Harbor City, California 90710, United States
Cedars Sinai Med Ctr, Los Angeles, California 90048, United States
UCLA CARE Ctr, Los Angeles, California 90095, United States
UCI Med Ctr, Orange, California 92668, United States
AIDS Community Research Consortium, Redwood City, California 94063, United States
Davies Med Ctr, San Francisco, California 94114, United States
Dr Patrick Joseph, San Ramone, California 94583, United States
Infectious Disease Research Consortium of Georgia, Atlanta, Georgia 30345, United States
Boston City Hosp, Boston, Massachusetts 02118, United States
Massachusetts Gen Hosp, Boston, Massachusetts 02114, United States
Beth Israel Med Ctr, New York, New York 10003, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States
Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States
Univ of Cincinnati, Cincinnati, Ohio 452670405, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States
Regional Med Ctr at Memphis, Memphis, Tennessee 38103, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Gathe, Joseph, M.D., Houston, Texas 77004, United States
Additional Information
Related publications: 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)
Last updated: June 23, 2005
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