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A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000863
  Purpose

To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026 concentrations and outcome/toxicity.


Condition Intervention Phase
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Sitamaquine
Phase II

MedlinePlus related topics:   AIDS    Pneumonia   

Drug Information available for:   WR 6026   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of WR 6026 for Pneumocystis Carinii Pneumonia in People With HIV Infection

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   45

Detailed Description:

All patients will receive an initial loading dose of WR 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of WR 6026 taken in a fasting state for 3 weeks.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Any medications not listed as excluded will be permitted on study.

[ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.]

Patients must have:

  • Documented HIV infection.
  • Documented PCP.
  • On a room air ABG, the PO2 value greater than or equal to 70 mm Hg and the (A-a) DO2 less than 35 mm Hg.
  • Signed informed consent from parent or legal guardian for those patients less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known hypersensitivity to quinolines.
  • If patient is unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study.

Concurrent Medication:

Excluded:

  • Any patient unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study (e.g., TMP/SMX, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine).
  • Methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites).

Patients with the following prior conditions or symptoms are excluded:

  • History of G6PD deficiency, hemoglobin M abnormality, or NAD methemoglobin reductase deficiency.

Prior Medication:

Excluded:

  • More than 24 hours receipt of anti-PCP treatment for the current episode of PCP. Receipt of prior PCP prophylaxis is permitted, as long as it is discontinued at study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000863

Locations
United States, Alabama
Univ of Alabama at Birmingham    
      Birmingham, Alabama, United States, 35294
United States, California
Univ of Southern California / LA County USC Med Ctr    
      Los Angeles, California, United States, 900331079
United States, Hawaii
Queens Med Ctr    
      Honolulu, Hawaii, United States, 96816
Univ of Hawaii    
      Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School    
      Chicago, Illinois, United States, 60611
Louis A Weiss Memorial Hosp    
      Chicago, Illinois, United States, 60640
United States, Indiana
Indiana Univ Hosp    
      Indianapolis, Indiana, United States, 462025250
Methodist Hosp of Indiana / Life Care Clinic    
      Indianapolis, Indiana, United States, 46202
Division of Inf Diseases/ Indiana Univ Hosp    
      Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21287
United States, New York
Univ of Rochester Medical Center    
      Rochester, New York, United States, 14642
Bellevue Hosp / New York Univ Med Ctr    
      New York, New York, United States, 10016
SUNY / Erie County Med Ctr at Buffalo    
      Buffalo, New York, United States, 14215
United States, Ohio
Univ of Cincinnati    
      Cincinnati, Ohio, United States, 452670405
Ohio State Univ Hosp Clinic    
      Columbus, Ohio, United States, 432101228
United States, Washington
Univ of Washington    
      Seattle, Washington, United States, 981224304

Sponsors and Collaborators

Investigators
Study Chair:     Dohn M    
Study Chair:     Petty B    
Study Chair:     Black J    
Study Chair:     Frame P    
  More Information


Publications:
Petty B, Black J, Hendrix C, Bassiakos Y, Feinberg J, Hafner R. Escalating multiple-dose safety and tolerance of WR 6026 in HIV-infected subjects. Int Conf AIDS. 1993 Jun 6-11;9(1):498 (abstract no PO-B29-2180)
 

Study ID Numbers:   ACTG 314
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000863
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections  
Pneumonia, Pneumocystis carinii  
Administration, Oral  
WR 6026  

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Pneumocystosis
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Infections
Respiratory Tract Diseases
HIV Infections
Lung Diseases
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on December 03, 2008




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