Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
- Conditions
- Pneumonia, Pneumocystis CariniiHIV Infections
- Registration Number
- NCT00000816
- Brief Summary
To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
- Detailed Description
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
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 (42)
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
🇹🇿Mbeya, Tanzania
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
USC CRS
🇺🇸Los Angeles, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
🇺🇸Omaha, Nebraska, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
🇺🇸Greensboro, North Carolina, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
🇺🇸Charlotte, North Carolina, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
🇺🇸Minneapolis, Minnesota, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States