DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Trimethoprim (Drug); Sulfamethoxazole (Drug); Leucovorin calcium (Drug)

Phase: N/A

Status: Completed

Sponsored by: Lederle Laboratories

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.

Clinical Details

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

Study design: Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

San Francisco Gen Hosp, San Francisco, California 941102859, United States
Additional Information

Related 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.


Last updated: June 23, 2005

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017