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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000863

First received: November 2, 1999
Last updated: March 30, 2012
Last Verified: March 2012
History of Changes
Purpose

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 2

Study Type: Interventional
Study Design: Primary Purpose: 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):

Enrollment: 45
Study Completion Date: July 1998

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

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
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

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: NCT00000863

Locations

United States, Alabama
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
United States, Hawaii
Queens Med. Ctr.
Honolulu, Hawaii, United States, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Weiss Memorial Hosp.
Chicago, Illinois, United States, 60640
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States, 46202
United States, New York
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
United States, Ohio
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 45267
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

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

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000863   History of Changes  
Other Study ID Numbers: ACTG 314  
  11289  
Study First Received: November 2, 1999  
Last Updated: March 30, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Administration, Oral
WR 6026

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.