- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000748
A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients.
Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.
Patients receive SMX/TMP orally on a daily or thrice-weekly basis. Patients are clinically evaluated every 4 months. Patients on daily SMX/TMP who develop a drug-related toxicity may be switched to thrice-weekly SMX/TMP. Duration of follow-up is 12 months.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94110
- Community Consortium of San Francisco
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Stanford, California, United States, 94305
- Stanford Univ School of Medicine
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Colorado
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Denver, Colorado, United States, 80204
- Denver CPCRA / Denver Public Hlth
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Delaware
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Wilmington, Delaware, United States, 19899
- Wilmington Hosp / Med Ctr of Delaware
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Veterans Administration Med Ctr / Regional AIDS Program
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Georgia
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Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta
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Illinois
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Chicago, Illinois, United States, 60657
- AIDS Research Alliance - Chicago
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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Maryland
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Baltimore, Maryland, United States, 21201
- Univ of Maryland at Baltimore
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Baltimore, Maryland, United States, 21201
- Baltimore Trials
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hosp
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Detroit, Michigan, United States, 48201
- Comprehensive AIDS Alliance of Detroit
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New Jersey
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Camden, New Jersey, United States, 08103
- Southern New Jersey AIDS Cln Trials / Dept of Med
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Newark, New Jersey, United States, 07103
- North Jersey Community Research Initiative
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- Partners Research
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Albuquerque, New Mexico, United States, 87131
- Univ Hosp / HIV - ID Clinic
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New York
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Bronx, New York, United States, 10456
- Bronx Lebanon Hosp Ctr
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Brooklyn, New York, United States, 11201
- Addiction Research and Treatment Corp
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New York, New York, United States, 10011
- Clinical Directors Network of Region II
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New York, New York, United States, 10037
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
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Oregon
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Portland, Oregon, United States, 97210
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Philadelphia FIGHT
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Virginia
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Richmond, Virginia, United States, 23298
- Richmond AIDS Consortium
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Washington
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Seattle, Washington, United States, 98144
- Univ of Washington / Pacific Med Ctr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- HIV infection.
- CD4 count <= 200 cells/mm3 OR a history of prior PCP.
- No active pneumocystosis. Patients or their guardians must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Known treatment-limiting reaction to sulfonamides or trimethoprim.
Concurrent Medication:
Excluded:
- Other PCP prophylaxis or medication with anti-PCP activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: W El-Sadr
- Study Chair: R Luskin-Hawk
Publications and helpful links
General Publications
- Simon PM, Morse EV, Besch L. Barriers to compliance among women co-enrolled in a PCP prophylaxis and compliance protocol. HIV Infect Women Conf. 1995 Feb 22-24:P109
- El-Sadr WM, Luskin-Hawk R, Yurik TM, Walker J, Abrams D, John SL, Sherer R, Crane L, Labriola A, Caras S, Pulling C, Hafner R. A randomized trial of daily and thrice-weekly trimethoprim-sulfamethoxazole for the prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected persons. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Clin Infect Dis. 1999 Oct;29(4):775-83. doi: 10.1086/520433.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Lung Diseases, Fungal
- Pneumocystis Infections
- Pneumonia
- Pneumonia, Pneumocystis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
Other Study ID Numbers
- CPCRA 006
- 11558 (Registry Identifier: DAIDS ES Registry Number)
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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