Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
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, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Sulfamethoxazole-Trimethoprim
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed if clinically indicated: Recombinant erythropoietin (rEPO) and G-CSF. Allowed for symptomatic treatment of mild study drug toxicity: Antipyretics and analgesics (ibuprofen). Antihistamines (diphenhydramine HCl). Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use). Systemic steroids. Patients must have: HIV infection. CD4 count <= 250 cells/mm3 OR history or presence of thrush. No history of confirmed or probable pneumocystosis. NOTE: Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment. This study is appropriate for prisoner participation. Coenrollment in ongoing ACTG antiretroviral studies is permitted provided no new study drugs are added to the patient's drug regimen for 4 weeks before or after initiation of SMX/TMP. Prior Medication: Allowed: Prior aerosolized pentamidine and dapsone for primary PCP prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known adverse reactions to sulfa, trimethoprim, or SMX/TMP. Inability to comply with dosing schedule or complete dosing record. Concurrent Medication: Excluded: Procysteine. Glutathione. N-acetylcysteine (NAC). Antihistamines (unless used for symptomatic treatment of study drug toxicity). Systemic corticosteroids (unless used for replacement purposes). Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity). TMP or sulfa drugs outside of the study. Prior Medication: Excluded at any time: Prior SMX/TMP as primary PCP prophylaxis. Excluded within 4 weeks prior to study entry: Initiation of antiretroviral agents. Initiation of anti-infective agents (including SMX/TMP for another indication). Excluded within 2 weeks prior to study entry: Antihistamines. Procysteine. Glutathione. N-acetylcysteine (NAC). Systemic corticosteroids (unless used for replacement purposes). Leucovorin calcium. TMP and sulfa drugs separately.
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 Florida Jacksonville NICHD CRS
- Univ. of Miami AIDS CRS
- Queens Med. Ctr.
- Univ. of Hawaii at Manoa, Leahi Hosp.
- Northwestern University CRS
- Cook County Hosp. CORE Ctr.
- Rush Univ. Med. Ctr. ACTG CRS
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- Methodist Hosp. of Indiana
- Tulane/LSU Maternal/Child CRS
- Johns Hopkins Adult AIDS CRS
- Massachusetts General Hospital ACTG CRS
- Bmc Actg Crs
- Beth Israel Deaconess - East Campus A0102 CRS
- Beth Israel Deaconess Med. Ctr., ACTG CRS
- Hennepin County Med. Ctr., Div. of Infectious Diseases
- University of Minnesota, ACTU
- St. Louis ConnectCare, Infectious Diseases Clinic
- Washington U CRS
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
- SUNY - Buffalo, Erie County Medical Ctr.
- NY Univ. HIV/AIDS CRS
- Beth Israel Med. Ctr. (Mt. Sinai)
- 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
- MetroHealth CRS
- Case CRS
- The Ohio State Univ. AIDS CRS
- Hosp. of the Univ. of Pennsylvania CRS
- University of Washington AIDS CRS
- San Juan City Hosp. PR NICHD CRS
- Mbeya Med. Research Program, Mbeya Referral Hosp. CRS