Trial | NCT00002002  Report issue

Official Title

A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Trimethoprim

Drug Sulfamethoxazole

Drug Leucovorin calcium

Criteria 

Inclusion Criteria

Patients must have the following:

Diagnosis of PCP.
Fit the CDC definition of AIDS.
Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or > 15mg/kg/day of the trimethoprim component.
Be receiving = or < 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization.
Must sign informed consent in accordance with FDA guidelines.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Cannot take oral medications.
Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.

Concurrent Medication:

Excluded:

Continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.

Patients with the following are excluded:

Cannot take oral medications.
Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.

Prior Medication:

Excluded:

> 48 hours of trimethoprim / sulfamethoxazole prior to randomization.
No Results Posted