A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides
- Conditions
- Pneumonia, Pneumocystis CariniiHIV Infections
- Registration Number
- NCT00000802
- Brief Summary
To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts \<= 200 cells/mm3 or \<= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides.
Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.
- Detailed Description
Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.
Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Case CRS
🇺🇸Cleveland, Ohio, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
USC CRS
🇺🇸Los Angeles, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
🇺🇸Washington, District of Columbia, United States
Emory Univ. Hemophilia Program Office
🇺🇸Atlanta, Georgia, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Weiss Memorial Hosp.
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
🇺🇸Iowa City, Iowa, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
🇺🇸Charlotte, North Carolina, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
🇺🇸Greensboro, North Carolina, United States
Wake County Health and Human Services CRS
🇺🇸Raleigh, North Carolina, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
🇹🇿Mbeya, Tanzania
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
🇺🇸Omaha, Nebraska, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
🇺🇸Minneapolis, Minnesota, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States