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:	Masking: Double-Blind 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

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

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
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Trimethoprim
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Leucovorin
Trimethoprim-Sulfamethoxazole Combination
Renal Agents
Antimalarials
Pneumonia, Pneumocystis
Mycoses
Antiparasitic Agents
Respiratory Tract Diseases

Respiratory Tract Infections
Therapeutic Uses
Vitamins
Micronutrients
Retroviridae Infections
Lung Diseases, Fungal
RNA Virus Infections
Vitamin B Complex
Immune System Diseases
Sulfamethoxazole
Growth Substances
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists

ClinicalTrials.gov processed this record on March 21, 2010