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
Completed · Not applicable
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002002
- Run by
- Lederle Laboratories
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- San Francisco Gen Hosp — San Francisco, California, United States
Full record on ClinicalTrials.gov
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