Status:
COMPLETED
A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Glaxo Wellcome
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE3
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-ri...
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 caus...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 1996
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00000748
End Date
November 1 1996
Last Update
November 4 2021
Active Locations (24)
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1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
2
Stanford Univ School of Medicine
Stanford, California, United States, 94305
3
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
4
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899