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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

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atovaquone
Pentamidine isethionate
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Pentamidine, Acquired Immunodeficiency Syndrome, atovaquone

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • East Bay AIDS Ctr
  • Kaiser Foundation Hosp
  • Cedars Sinai Med Ctr
  • UCLA CARE Ctr
  • UCI Med Ctr
  • AIDS Community Research Consortium
  • Davies Med Ctr
  • Dr Patrick Joseph
  • Infectious Disease Research Consortium of Georgia
  • Massachusetts Gen Hosp
  • Boston City Hosp
  • Beth Israel Med Ctr
  • Saint Vincent's Hosp and Med Ctr
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Univ of Cincinnati
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Buckley Braffman Stern Med Associates
  • Regional Med Ctr at Memphis
  • Gathe, Joseph, M.D.
  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00001996
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
May 1992
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Pentamidine, Acquired Immunodeficiency Syndrome, atovaquone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atovaquone
Intervention Type
Drug
Intervention Name(s)
Pentamidine isethionate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Kaiser Foundation Hosp
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Cedars Sinai Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Dr Patrick Joseph
City
San Ramone
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Infectious Disease Research Consortium of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston City Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Regional Med Ctr at Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Gathe, Joseph, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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Learn more about this trial

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

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