A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
2 other identifiers
interventional
2,500
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
November 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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 D.C., 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
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
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456, 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
Related Publications (2)
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
BACKGROUNDEl-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.
PMID: 10589887BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
W El-Sadr
- STUDY CHAIR
R Luskin-Hawk
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
November 1, 1996
Last Updated
November 4, 2021
Record last verified: 2021-10