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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trimethoprim

Sulfamethoxazole

Dapsone

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Dapsone, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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 Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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.

Sites / Locations

Jacobus Pharmaceutical Co

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002283

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Jacobus Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00002283

Brief Title

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

Official Title

Randomized Prospective Study of Dapsone Versus Trimethoprim-Sulfamethoxazole in the Treatment of First Episode Pneumocystis Carinii Pneumonia in AIDS Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 1989

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Jacobus Pharmaceutical

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Pneumocystis Carinii, HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Trimethoprim

Intervention Type

Drug

Intervention Name(s)

Sulfamethoxazole

Intervention Type

Drug

Intervention Name(s)

Dapsone

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Jacobus Pharmaceutical Co

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Pneumonia, Pneumocystis Carinii, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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