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

L

Lederle Laboratories

Status

Completed

Conditions

Pneumonia, Pneumocystis Carinii
HIV Infections

Treatments

Drug: Sulfamethoxazole
Drug: Leucovorin calcium
Drug: Trimethoprim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002002
056A
76-9

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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