Completed

Dapsone vs Trimethoprim-Sulfamethoxazole for First Episode Pneumocystis Carinii Pneumonia in AIDS Patients

What is being tested

Trimethoprim

+ Sulfamethoxazole

+ Dapsone

Drug

Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

See protocol details

Summary

Principal SponsorJacobus Pharmaceutical

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on treating the first episode of a specific type of pneumonia, called Pneumocystis carinii pneumonia (PCP), in patients with AIDS. The goal is to evaluate the effectiveness of a therapy combining dapsone and trimethoprim. The research aims to compare this treatment with another common medication, trimethoprim-sulfamethoxazole (TMP/PurposeX). The importance of this study lies in understanding which treatment works better and causes fewer side effects, potentially improving care for AIDS patients with PCP. During the study, participants receive either the dapsone plus trimethoprim therapy or the trimethoprim-sulfamethoxazole (TMP/PurposeX) treatment. The study measures the effectiveness of each treatment by monitoring the patients' health and symptoms. It also keeps track of any side effects to determine which treatment is safer and more suitable for outpatient treatment, meaning patients can recover at home instead of staying in the hospital.

NCT00002283

Principal SponsorJacobus Pharmaceutical

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesOpportunistic InfectionsPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsPneumocystis InfectionsAcquired Immunodeficiency SyndromePneumonia, PneumocystisHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

4 inclusion criteria required to participate

Hospitalized patients with first episode of Pneumocystis carinii pneumonia (PCP) documented by GIEMSA or methenamine stain

Patients must be expected to survive 1 week without therapy

Patients must be willing and able to give informed consent

Patients must have less than 48 hours of treatment for Pneumocystis carinii pneumonia (PCP) for this episode

3 exclusion criteria prevent from participating

History of allergic reaction to dapsone

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Jacobus Pharmaceutical Co

Princeton, United StatesOpen Jacobus Pharmaceutical Co in Google Maps

CompletedOne Study Center