Sulfamethoxazole |
Gantanol |
Clinical Trial: 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.
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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 | Treatment or Intervention |
|---|---|
| Pneumonia, Pneumocystis carinii HIV Infections | Drug: Trimethoprim Drug: Sulfamethoxazole Drug: Leucovorin calcium |
MedlinePlus related topics: AIDS; Fungal Infections; Pneumocystis Carinii Infections; Pneumonia; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment, Double-Blind
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: 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.
Location Information
California
San Francisco Gen Hosp, San Francisco, California, 941102859, United States
More Information
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.
Record last reviewed: July 1992
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002002
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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