A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

Completed · Phase 3

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000748

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2500

Expected to finish

1996-11-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Community Consortium of San Francisco — San Francisco, California, United States
• Stanford Univ School of Medicine — Stanford, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
• Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Baltimore Trials — Baltimore, Maryland, United States
• Univ of Maryland at Baltimore — Baltimore, Maryland, United States
• Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners Research — Albuquerque, New Mexico, United States
• Univ Hosp / HIV - ID Clinic — Albuquerque, New Mexico, United States
• Addiction Research and Treatment Corp — Brooklyn, New York, United States
• Clinical Directors Network of Region II — New York, New York, United States
• Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
• Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Richmond AIDS Consortium — Richmond, Virginia, United States
• Univ of Washington / Pacific Med Ctr — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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