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

Sponsor

Jacobus Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00002283

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Trimethoprim Drug: Sulfamethoxazole Drug: Dapsone	N/A

Study Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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.