A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS
This study has been completed.
Sponsor:
Jacobus Pharmaceutical
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002283
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1989
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Purpose
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 | Intervention |
|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimethoprim Drug: Sulfamethoxazole Drug: Dapsone |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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- Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002283
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002283
Locations
| United States, New Jersey | |
| Jacobus Pharmaceutical Co | |
| Princeton, New Jersey, United States, 08540 | |
Sponsors and Collaborators
Jacobus Pharmaceutical
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002283 History of Changes |
| Other Study ID Numbers: | 007A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Dapsone Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Pneumocystis Lung Diseases Lung Diseases, Fungal Mycoses Pneumocystis Infections Respiratory Tract Diseases Respiratory Tract Infections Dapsone Sulfamethoxazole Trimethoprim Trimethoprim-Sulfamethoxazole Combination Anti-Bacterial Agents |
Anti-Infective Agents Anti-Infective Agents, Urinary Antimalarials Antiparasitic Agents Antiprotozoal Agents Enzyme Inhibitors Folic Acid Antagonists Leprostatic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Renal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015