A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
- Conditions
- Pneumonia, Pneumocystis CariniiHIV Infections
- Registration Number
- NCT00001028
- Brief Summary
To compare the safety and efficacy of aerosolized pentamidine and dapsone in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients who are intolerant to trimethoprim and/or sulfonamides.
Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause side effects. This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole.
- Detailed Description
Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause side effects. This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole.
Patients are evenly divided between two treatment arms to receive either aerosolized pentamidine every 4 weeks or dapsone orally three times weekly. Follow-up data is collected every 3 months, and patients are clinically evaluated every 6 months. Patients who develop PCP or a severe or persistent study drug toxicity may be switched to the alternative study drug at the clinician's discretion. Average duration of follow-up is 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Community Consortium of San Francisco
🇺🇸San Francisco, 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, District of Columbia, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Wishard Hosp / Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States