A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
NCT ID: NCT00000748
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2500 participants
INTERVENTIONAL
1996-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Sulfamethoxazole-Trimethoprim
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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W El-Sadr
Role: STUDY_CHAIR
R Luskin-Hawk
Role: STUDY_CHAIR
Locations
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Community Consortium of San Francisco
San Francisco, California, United States
Stanford Univ School of Medicine
Stanford, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Baltimore Trials
Baltimore, Maryland, United States
Univ of Maryland at Baltimore
Baltimore, Maryland, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners Research
Albuquerque, New Mexico, United States
Univ Hosp / HIV - ID Clinic
Albuquerque, New Mexico, United States
Addiction Research and Treatment Corp
Brooklyn, New York, United States
Clinical Directors Network of Region II
New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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11558
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 006
Identifier Type: -
Identifier Source: org_study_id