|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | U.S. Bioscience |
|---|---|
| Collaborator: |
Jacobus Pharmaceutical |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002120 |
Purpose
To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Trimethoprim Drug: Sulfamethoxazole Drug: Dapsone Drug: Leucovorin calcium |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| Official Title: | Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
Prior history of serious or life-threatening intolerance to TMP/SMX. (NOTE:
Prior Medication:
Excluded:
Contacts and Locations
More Information
| Study ID Numbers: | 224A, TMTX A009 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002120 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Trimethoprim-Sulfamethoxazole Combination Trimetrexate Pneumonia, Pneumocystis carinii Leucovorin |
Dapsone Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
|
Antimetabolites Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Trimethoprim Antimetabolites, Antineoplastic Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Trimethoprim-Sulfamethoxazole Combination Renal Agents Infection Anti-Bacterial Agents |
Antimalarials Pneumonia, Pneumocystis Mycoses Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections Antifungal Agents Vitamins Therapeutic Uses Dapsone Micronutrients Retroviridae Infections Trimetrexate Lung Diseases, Fungal RNA Virus Infections |