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
  Purpose

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.


Condition Intervention Phase
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Atovaquone
Drug: Pentamidine isethionate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001996

Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94704
Kaiser Foundation Hosp
Harbor City, California, United States, 90710
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
UCI Med Ctr
Orange, California, United States, 92668
AIDS Community Research Consortium
Redwood City, California, United States, 94063
Davies Med Ctr
San Francisco, California, United States, 94114
Dr Patrick Joseph
San Ramone, California, United States, 94583
United States, Georgia
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, United States, 30345
United States, Massachusetts
Boston City Hosp
Boston, Massachusetts, United States, 02118
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Beth Israel Med Ctr
New York, New York, United States, 10003
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Regional Med Ctr at Memphis
Memphis, Tennessee, United States, 38103
United States, Texas
Gathe, Joseph, M.D.
Houston, Texas, United States, 77004
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Glaxo Wellcome
  More Information

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)

ClinicalTrials.gov Identifier: NCT00001996     History of Changes
Other Study ID Numbers: 053B, 05
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Trimethoprim-Sulfamethoxazole Combination
Pneumonia, Pneumocystis carinii
Pentamidine
Acquired Immunodeficiency Syndrome
atovaquone

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Pneumonia
Pneumonia, Pneumocystis
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lung Diseases
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atovaquone
Pentamidine
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

ClinicalTrials.gov processed this record on October 20, 2014