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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001996
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1992

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00001996 on ClinicalTrials.gov Archive Site
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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
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
  • Drug: Atovaquone
  • Drug: Pentamidine isethionate
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001996
053B, 05
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
May 1992

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP