- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002002
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
June 23, 2005 updated by: Lederle Laboratories
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 941102859
- San Francisco Gen Hosp
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
July 1, 1992
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Slow Virus Diseases
- Lung Diseases, Fungal
- Pneumocystis Infections
- HIV Infections
- Pneumonia
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Pneumonia, Pneumocystis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Protective Agents
- Micronutrients
- Cytochrome P-450 Enzyme Inhibitors
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antidotes
- Vitamin B Complex
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Leucovorin
- Calcium
- Levoleucovorin
- Trimethoprim
- Sulfamethoxazole
Other Study ID Numbers
- 056A
- 76-9
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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