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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Lederle Laboratories
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002002

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:	Treatment, Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Pneumonia

Drug Information available for: Leucovorin Citrovorum factor Sulfamethoxazole Trimethoprim Leucovorin Calcium Folinic acid calcium salt pentahydrate Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Publications:

Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7.

Study ID Numbers:	056A, 76-9
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002002 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Anti-Infective Agents
Communicable Diseases
Antiprotozoal Agents
Trimethoprim
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Leucovorin
Trimethoprim-Sulfamethoxazole Combination
Renal Agents
Infection
Antimalarials
Pneumonia, Pneumocystis
Mycoses

Antiparasitic Agents
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Vitamins
Syndrome
Micronutrients
Retroviridae Infections
Lung Diseases, Fungal
RNA Virus Infections
Vitamin B Complex
Disease
Sulfamethoxazole
Immune System Diseases

ClinicalTrials.gov processed this record on November 09, 2009