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 - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002002 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	Pneumonia, Pneumocystis Carinii HIV Infections
Intervention ^ICMJE	Drug: Trimethoprim Drug: Sulfamethoxazole Drug: Leucovorin calcium
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002002
Responsible Party
Study ID Numbers ^ICMJE	056A, 76-9
Study Sponsor ^ICMJE	Lederle Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	July 1992
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP