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
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