Clinical Trials

MainTitle

A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

This study has been completed
Sponsor
Jacobus Pharmaceutical


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002283

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 1989
History of Changes
Purpose

Purpose

Evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first episode of Pneumocystis carinii pneumonia (PCP) in AIDS patients. Compare the rates and severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (TMP / PurposeX). Establish relative toxicities with regard to suitability for outpatient treatment.

Condition Intervention
Pneumonia, Pneumocystis Carinii
HIV Infections

Drug : Trimethoprim
Drug : Sulfamethoxazole
Drug : Dapsone

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Prospective Study of Dapsone Versus Trimethoprim-Sulfamethoxazole in the Treatment of First Episode Pneumocystis Carinii Pneumonia in AIDS Patients

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Exclusion Criteria
Concurrent Medication:
Excluded:

  • Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).

  • Patients with the following are excluded:
  • History of allergic reaction to dapsone.
  • Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).
  • Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.

  • Prior Medication:
    Excluded:
  • Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).

  • Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.
    Hospitalized patients with first episode of Pneumocystis carinii pneumonia (PCP) documented by GIEMSA or methenamine stain.
  • Patients must:
  • Be willing and able to give informed consent.
  • Be expected to survive 1 week without therapy.
  • Have less than 48 hours of treatment for Pneumocystis carinii pneumonia (PCP) for this
episode.

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: NCT00002283

Locations

United States, New Jersey
Jacobus Pharmaceutical Co
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Jacobus Pharmaceutical
More Information

More Information


Responsible Party: Jacobus Pharmaceutical  
ClinicalTrials.gov Identifier: NCT00002283   History of Changes  
Other Study ID Numbers: 007A  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Trimethoprim-Sulfamethoxazole Combination
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Dapsone
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Pneumonia
Pneumonia, Pneumocystis
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Dapsone
Sulfamethoxazole

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.