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NCT00002283 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002283
Other study ID # 007A
Secondary ID
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date August 1989
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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- Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Trimethoprim

• Sulfamethoxazole

• Dapsone

Locations
Country Name City State
United States Jacobus Pharmaceutical Co Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Jacobus Pharmaceutical

Country where clinical trial is conducted

United States, 

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