A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
2500
Participants Needed
24
Research Sites
N/A
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
Trial Site Locations
How is the study designed?
Frequently Asked Questions
Research Publications
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
G
Glaxo Wellcome
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 24 locations
1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
Status Unknown
2
Stanford Univ School of Medicine
Stanford, California, United States, 94305
Status Unknown
3
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
Status Unknown
4
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
Status Unknown
5
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States, 20422
Status Unknown
6
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Status Unknown
7
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Status Unknown
8
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
Status Unknown
9
Baltimore Trials
Baltimore, Maryland, United States, 21201
Status Unknown
10
Univ of Maryland at Baltimore
Baltimore, Maryland, United States, 21201
Status Unknown
11
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Status Unknown
12
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Status Unknown
13
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States, 08103
Status Unknown
14
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
Status Unknown
15
Partners Research
Albuquerque, New Mexico, United States, 87131
Status Unknown
16
Univ Hosp / HIV - ID Clinic
Albuquerque, New Mexico, United States, 87131
Status Unknown
17
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
Status Unknown
18
Clinical Directors Network of Region II
New York, New York, United States, 10011
Status Unknown
19
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
20
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10456
Status Unknown
21
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
Status Unknown
22
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Status Unknown
23
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298
Status Unknown
24
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States, 98144
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
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).
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
G
Glaxo Wellcome
Collaborating Sponsor
A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients | DecenTrialz