A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention: Sulfamethoxazole-Trimethoprim (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
W El-Sadr, Study Chair
R Luskin-Hawk, Study Chair
Summary
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.
Clinical Details
Official title: A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
Study design: Treatment, Parallel Assignment, Safety Study
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Community Consortium of San Francisco, San Francisco, California 94110, United States
Stanford Univ School of Medicine, Stanford, California 943055107, United States
Denver CPCRA / Denver Public Hlth, Denver, Colorado 802044507, United States
Wilmington Hosp / Med Ctr of Delaware, Wilmington, Delaware 19899, United States
Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia 20422, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana 70112, United States
Univ of Maryland at Baltimore, Baltimore, Maryland 21201, United States
Baltimore Trials, Baltimore, Maryland 21201, United States
Henry Ford Hosp, Detroit, Michigan 48202, United States
Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States
North Jersey Community Research Initiative, Newark, New Jersey 071032842, United States
Southern New Jersey AIDS Cln Trials / Dept of Med, Camden, New Jersey 08103, United States
Univ Hosp / HIV - ID Clinic, Albuquerque, New Mexico 87131, United States
Partners Research, Albuquerque, New Mexico 871315271, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10456, United States
Clinical Directors Network of Region II, New York, New York 10011, United States
Addiction Research and Treatment Corp, Brooklyn, New York 11201, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 972109951, United States
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Richmond AIDS Consortium, Richmond, Virginia 23298, United States
Univ of Washington / Pacific Med Ctr, Seattle, Washington 98144, United States
Additional Information
Click here for more information about Sulfamethoxazole-Trimethoprim
Related 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.
Last updated: June 23, 2005
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