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

A Phase II Study of WR 6026 for Pneumocystis Carinii Pneumonia in People With HIV Infection

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Pneumonia, Pneumocystis Carinii
• Intervention / Treatment: Drug: Sitamaquine

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.

• Study Type: Interventional
• Enrollment: 45
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Petty BG, Black JR, Hendrix CW, Lewis LD, Basiakos Y, Feinberg J, Pattison DG, Hafner R. Escalating multiple-dose safety and tolerance study of oral WR 6026 in HIV-infected subjects: AIDS clinical trials group 173. J Acquir Immune Defic Syndr. 1999 May 1;21(1):26-32. doi: 10.1097/00126334-199905010-00004.

Study record dates

Study Major Dates

• Study Completion (Actual): July 1, 1998

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Administration, Oral; WR 6026
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Slow Virus Diseases; Lung Diseases, Fungal; Pneumocystis Infections; HIV Infections; Infections; Pneumonia; Acquired Immunodeficiency Syndrome; Pneumonia, Pneumocystis
• Other Study ID Numbers: ACTG 314; 11289 (Registry Identifier: DAIDS ES Registry Number)