Search / Trial NCT00002002

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

Launched by LEDERLE LABORATORIES · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Trimethoprim Sulfamethoxazole Combination Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Lederle Laboratories

Lederle Laboratories, a distinguished pharmaceutical company, is recognized for its commitment to advancing healthcare through innovative research and development. With a rich history in vaccine production and biologics, Lederle Laboratories focuses on creating effective therapeutic solutions that address critical medical needs. The organization emphasizes rigorous clinical trial methodologies and adherence to regulatory standards, ensuring the safety and efficacy of its products. By fostering collaborations with healthcare professionals and research institutions, Lederle Laboratories strives to contribute significantly to the improvement of patient outcomes and public health.

Locations

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials