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DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)

NCT00302341 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-03-07

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the non-inferiority of pafuramidine maleate (DB289)versus trimethoprim-sulfamethoxazole (TMP-SMX)for the treatment of mild to moderately severe Pneumocystis pneumonia (PCP).

Conditions

  • Pneumonia, Interstitial Plasma Cell
  • Pneumocystis Carinii Pneumonia
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections

Interventions

DRUG

Pafuramidine maleate (DB289)

Oral tablet, 100 mg bid, 14 days

DRUG

Trimethoprim-Sulfamethoxazole (TMP-SMX)

15 mg/kg, oral tablet split tid X 21 days

Sponsors & Collaborators

  • Immtech Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Judith Aberg, MD · NYU School of Medicine

  • Preston Church, MD · Medical University of South Carolina

  • Laurence Huang, MD · University of California, San Francisco

  • Amanda Peppercorn, MD · UNC AIDS Clinical Trials- School of Medicine

  • Carl Fichtenbaum, MD · University of Cincinnati

  • Kathleen Mullane, DO · University of Chicago

  • Jose Vazquez, MD · Henry Ford Health Systems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00302341 on ClinicalTrials.gov