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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Lederle Laboratories


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002002

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1992
History of Changes
Purpose

Purpose

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.

Condition Intervention
Pneumonia, Pneumocystis Carinii
HIV Infections

Drug : Trimethoprim
Drug : Sulfamethoxazole
Drug : Leucovorin calcium

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002002

Locations

United States, California
San Francisco Gen Hosp
San Francisco, California, United States, 941102859

Sponsors and Collaborators

Lederle Laboratories
More Information

More Information


Responsible Party: Lederle Laboratories  
ClinicalTrials.gov Identifier: NCT00002002   History of Changes  
Other Study ID Numbers: 056A  
  76-9  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Trimethoprim-Sulfamethoxazole Combination
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Pneumonia
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Pneumonia, Pneumocystis
Levoleucovorin
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Sulfamethoxazole

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.