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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS    Pneumonia   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Calcium gluconate    Sulfamethoxazole    Trimethoprim    Trimethoprim-sulfamethoxazole combination   

U.S. FDA Resources

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
  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:

Study ID Numbers:   056A, 76-9
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002002
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  

Study placed in the following topic categories:
Opportunistic Infections
Trimethoprim
Sexually Transmitted Diseases, Viral
Sulfamethoxazole
Pneumocystosis
Acquired Immunodeficiency Syndrome
Leucovorin
Trimethoprim-Sulfamethoxazole Combination
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Infections
Respiratory Tract Diseases
HIV Infections
Lung Diseases
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
RNA Virus Infections
Slow Virus Diseases
Disease
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Renal Agents
Infection
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Vitamins
Lentivirus Infections
Micronutrients

ClinicalTrials.gov processed this record on September 19, 2008




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