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 on November 2, 1999. Last Updated on 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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/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

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

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.

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
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Leucovorin
Levoleucovorin
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012