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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

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trimethoprim
Sulfamethoxazole
Leucovorin calcium
Sponsored by
Lederle Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco Gen Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Lederle Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00002002
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
July 1992
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lederle Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Trimethoprim
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole
Intervention Type
Drug
Intervention Name(s)
Leucovorin calcium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7930736
Citation
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. doi: 10.1093/infdis/170.4.912.
Results Reference
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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

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