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
Pneumonia, Pneumocystis Carinii, HIV Infections
About this trial
This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Primaquine, Dapsone, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Clindamycin, Sulfamethoxazole-Trimethoprim
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Erythropoietin. Maintenance treatment with investigational triazoles (e.g., itraconazole). Antiemetics for nausea/vomiting, antihistamines for rash/pruritus, antipyretics for systemic symptoms (fever, headache, etc.) should be used for treatment of symptoms. Nonsteroidal antiinflammatory agents may be used for control of myalgias, headache, etc. Concurrent Treatment: Allowed: Blood transfusions. Patients must have the following: Pneumocystis carinii pneumonia. HIV infection. Willing and able to sign informed consent. Patients under 18 years of age may enter with consent of parent or guardian. Prior Medication: Allowed: Up to 24 hours of treatment with sulfamethoxazole/trimethoprim (SMX/TMP), dapsone / trimethoprim, or clindamycin / primaquine, or one dose of pentamidine for this episode of Pneumocystis carinii pneumonia (PCP). Prior PCP prophylaxis. Required: Adjunctive prednisone therapy in patients with (A-a) DO2 of 35 - 45 torr receiving acute anti-PCP treatment. Exclusion Criteria Co-existing Condition: Patients with the following conditions and diseases are excluded: Positive screen for glucose-6-phosphate dehydrogenase deficiency. Known NAD methemoglobin reductase deficiency and/or known hemoglobin M abnormality. Concurrent Medication: Excluded: Zidovudine (AZT). Ganciclovir. GM-CSF or G-CSF. Rifampin. Rifabutin. Corticosteroids (in patients with baseline (A-a) DO2 < 35 torr). Investigational drugs not specifically allowed. Folinic acid. Patients with the following are excluded: Previous dose-limiting intolerance to sulfones, trimethoprim, clindamycin, or primaquine. Requirement for other medications potentially effective in the treatment of Pneumocystis carinii pneumonia (PCP) (e.g., pyrimethamine and sulfadiazine). Prior enrollment in ACTG 108. Presence of other concurrent pulmonary pathology that would make interpretation of response to antipneumocystis therapy difficult. Inability to take oral therapy. Prior Medication: Excluded: Acute treatment doses of anti-Pneumocystis carinii pneumonia agents within 30 days prior to study entry except as noted above. Systemic steroids above adrenal replacement doses within 7 days prior to study entry (except for patients with (A-a) DO2 of 35 - 45 torr who receive prednisone in conjunction with acute anti-PCP treatment).
Sites / Locations
- USC CRS
- Stanford CRS
- Ucsf Aids Crs
- Santa Clara Valley Med. Ctr.
- San Mateo County AIDS Program
- Harbor-UCLA Med. Ctr. CRS
- University of Colorado Hospital CRS
- Univ. of Hawaii at Manoa, Leahi Hosp.
- Rush Univ. Med. Ctr. ACTG CRS
- Northwestern University CRS
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- Methodist Hosp. of Indiana
- Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
- Johns Hopkins Adult AIDS CRS
- Massachusetts General Hospital ACTG CRS
- Beth Israel Deaconess - East Campus A0102 CRS
- University of Minnesota, ACTU
- Washington U CRS
- SUNY - Buffalo, Erie County Medical Ctr.
- Beth Israel Med. Ctr. (Mt. Sinai)
- NY Univ. HIV/AIDS CRS
- Cornell University A2201
- NYU Med. Ctr., Dept. of Medicine
- Univ. of Rochester ACTG CRS
- Unc Aids Crs
- Carolinas HealthCare System, Carolinas Med. Ctr.
- Regional Center for Infectious Disease, Wendover Medical Center CRS
- Univ. of Cincinnati CRS
- Case CRS
- The Ohio State Univ. AIDS CRS
- Pitt CRS
- University of Washington AIDS CRS