Search / Trial NCT00001016

A Treatment Protocol for the Use of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis Carinii Pneumonia and Serious Intolerance to Approved Therapies

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Trimetrexate Pneumonia, Pneumocystis Carinii Quinazolines Infusions, Intravenous Injections, Intravenous Leucovorin Drug Evaluation Drug Therapy, Combination Administration, Oral Acquired Immunodeficiency Syndrome Antiprotozoal Agents Aids Related Complex

Description

The drugs usually used to treat PCP in AIDS patients (trimethoprim / sulfamethoxazole and pentamidine) have had to be discontinued in many patients because of severe adverse effects. Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial because it has been found to be very active against the PCP organism in laboratory tests. In a preliminary trial, TMTX in combination with LCV has been effective against PCP with fewer and less severe adverse effects. AMENDED: 08/01/90. As of August 31, 1989, 437 patients were enrolled into uncontrolled studies of trimetr...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Blood pressure medication.
  • Concurrent Treatment:
  • Allowed:
  • Blood products.
  • Ventilatory support.
  • Patients must have the following:
  • Diagnosis of Pneumocystis carinii pneumonia (PCP).
  • Be HIV positive by ELISA, HIV culture, or p24 antigenemia; or be a member of an identified risk group.
  • Intolerant to trimethoprim / sulfamethoxazole (TMP / SMX).
  • Intolerant to pentamidine.
  • Prior Medication:
  • Allowed:
  • Trimethoprim / sulfamethoxazole trials.
  • Pentamidine trials.
  • Myelosuppressive agents.
  • Nephrotoxic agents.
  • Zidovudine (AZT).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients who do not meet the inclusion criteria are excluded.
  • Concurrent Medication:
  • Excluded:
  • Myelosuppressive agents.
  • Nephrotoxic agents.
  • Other investigational drugs including high-dose steroids (exceeding physiologic replacement doses).
  • Patients who do not meet the inclusion criteria are excluded.

Attachments

readout_NCT00001016_2023-12-10.pdf

4.5 MB

NCT00001016_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Morris Plains, New Jersey, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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