A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS
- Conditions
- HIV InfectionsPneumonia, Pneumocystis Carinii
- Registration Number
- NCT00000640
- Brief Summary
To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP.
The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
- Detailed Description
The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
Patients with confirmed PCP are randomized into one of three treatment groups. Group A receives SMX/TMP. Half of group A receives dapsone placebo (placebo is an inactive substance) daily plus trimethoprim placebo; the other half receives clindamycin placebo plus primaquine placebo. Group B is given dapsone plus trimethoprim. Half of group B receives SMX/TMP placebo; the other half receives clindamycin placebo plus primaquine placebo. Group C is given clindamycin plus primaquine. Half of group C receives SMX/TMP placebo, the other half receives dapsone placebo plus trimethoprim placebo. Treatment lasts 21 days; dosages will be adjusted for patients weighing less than 50 kg and more than 80 kg. Patients with a history of intolerance to SMX/TMP for whom rechallenge is considered medically contraindicated may be randomized to one of the non-sulfamethoxazole-containing arms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
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 (32)
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
USC CRS
🇺🇸Los Angeles, California, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
🇺🇸Greensboro, North Carolina, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
🇺🇸New Orleans, Louisiana, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, 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
Cornell University A2201
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
🇺🇸Charlotte, North Carolina, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States