Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lederle Laboratories
Treatments:
Calcium
Leucovorin
Levoleucovorin
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
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.