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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)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Sulfamethoxazole-Trimethoprim (Drug)

Phase: Phase 3

Status: Completed

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: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: 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.

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 94305, United States

Denver CPCRA / Denver Public Hlth, Denver, Colorado 80204, 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

Baltimore Trials, Baltimore, Maryland 21201, United States

Univ of Maryland at Baltimore, Baltimore, Maryland 21201, United States

Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

Southern New Jersey AIDS Cln Trials / Dept of Med, Camden, New Jersey 08103, United States

North Jersey Community Research Initiative, Newark, New Jersey 07103, United States

Partners Research, Albuquerque, New Mexico 87131, United States

Univ Hosp / HIV - ID Clinic, Albuquerque, New Mexico 87131, United States

Bronx Lebanon Hosp Ctr, Bronx, New York 10456, United States

Addiction Research and Treatment Corp, Brooklyn, New York 11201, United States

Clinical Directors Network of Region II, New York, New York 10011, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, 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: September 28, 2013

Page last updated: August 23, 2015

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