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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

Phase 3
Completed
Conditions
Pneumonia, Pneumocystis Carinii
HIV Infections
Registration Number
NCT00000748
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2500
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (24)

Community Consortium of San Francisco

🇺🇸

San Francisco, California, United States

AIDS Research Consortium of Atlanta

🇺🇸

Atlanta, Georgia, United States

AIDS Research Alliance - Chicago

🇺🇸

Chicago, Illinois, United States

Philadelphia FIGHT

🇺🇸

Philadelphia, Pennsylvania, United States

Univ of Washington / Pacific Med Ctr

🇺🇸

Seattle, Washington, United States

North Jersey Community Research Initiative

🇺🇸

Newark, New Jersey, United States

Wilmington Hosp / Med Ctr of Delaware

🇺🇸

Wilmington, Delaware, United States

Southern New Jersey AIDS Cln Trials / Dept of Med

🇺🇸

Camden, New Jersey, United States

Veterans Administration Med Ctr / Regional AIDS Program

🇺🇸

Washington, District of Columbia, United States

Denver CPCRA / Denver Public Hlth

🇺🇸

Denver, Colorado, United States

Comprehensive AIDS Alliance of Detroit

🇺🇸

Detroit, Michigan, United States

Henry Ford Hosp

🇺🇸

Detroit, Michigan, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp

🇺🇸

Portland, Oregon, United States

Stanford Univ School of Medicine

🇺🇸

Stanford, California, United States

Univ of Maryland at Baltimore

🇺🇸

Baltimore, Maryland, United States

Baltimore Trials

🇺🇸

Baltimore, Maryland, 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

Harlem AIDS Treatment Group / Harlem Hosp Ctr

🇺🇸

New York, New York, United States

Clinical Directors Network of Region II

🇺🇸

New York, New York, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

🇺🇸

New Orleans, Louisiana, United States

Bronx Lebanon Hosp Ctr

🇺🇸

Bronx, New York, United States

Richmond AIDS Consortium

🇺🇸

Richmond, Virginia, United States

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