A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention: Trimethoprim (Drug); Sulfamethoxazole (Drug); Dapsone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Jacobus Pharmaceutical
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.
Clinical Details
Official title: Randomized Prospective Study of Dapsone Versus Trimethoprim-Sulfamethoxazole in the Treatment of First Episode Pneumocystis Carinii Pneumonia in AIDS Patients
Study design: Allocation: Randomized, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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will be withdrawn from the study and treated with another regimen.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Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from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.
Locations and Contacts
Jacobus Pharmaceutical Co, Princeton, New Jersey 08540, United States
Additional Information
Last updated: June 23, 2005
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