Date: Wed, 14 Dec 1994 15:40:50 -0500 From: awilson@smtpinet.aspensys.com (Wilson, Anne) NEW INFORMATION FROM ACTIS The AIDS Clinical Trials Information Service (ACTIS) is a central resource providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV. This service is a Public Health Service project produced collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. NAC ONLINE, the computerized information service of the CDC National AIDS Clearinghouse, will alert you to any new information collected by ACTIS. A description of the most recent clinical trial added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist. On request, you can also obtain a printout of a customized search of the clinical trials databases. The information can also be accessed directly by subscribers through two online databases, AIDSTRIALS and AIDSDRUGS, available through the National Library of Medicine. AIDS CLINICAL TRIALS INFORMATION SERVICE 1-800-TRIALS-A (1-800-874-2572) FAX: 1-301-738-6616 TTY/TDD: 1-800-243-7012 International Line: 1-301-217-0023 ************************************************************************** PROTOCOL NUMBER: NIAID ACTG 268. TITLE: Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis carinii Pneumonia Prophylaxis. PHASE: Phase IV. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV seropositive by ELISA, Western blot, HIV serum p24 antigen, or a positive HIV culture. 2. CD4 count <= 250 cells/mm3 OR history or presence of thrush regardless of CD4 count. 3. NO history of confirmed or probable pneumocystosis. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4 count <= 250 cells/mm3 OR history or presence of thrush. 3. NO history of confirmed or probable pneumocystosis. NOTE: Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment. NOTE: This study is appropriate for prisoner participation. NOTE: 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 TMP/SMX. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. PRIOR MEDICATION: Allowed: Prior aerosolized pentamidine and dapsone for primary PCP prophylaxis. CONCURRENT MEDICATION: Allowed if clinically indicated: Recombinant erythropoietin (rEPO) and G-CSF. Allowed for symptomatic treatment of mild study drug toxicity: 1. Antipyretics and analgesics (ibuprofen). 2. Antihistamines (diphenhydramine HCl). 3. Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use). 4. Systemic steroids. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 9.2 g/dl. (men); >= 8.5 g/dl (women). PLATELET COUNT: >= 50000 platelets/mm3. CD4 (T4 CELL) COUNT: <= 250 cells/mm3. OR a presence of thrush regardless of CD4 count. ( 0 - 100 - 200 ). SGOT (AST): <= 10 x ULN. (ULN = upper limit of normal). SGPT (ALT): <= 10 x ULN. CREATININE: <= 2.5 x ULN. OTHER LABORATORY VALUES: Absolute neutrophils >= 750 cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 12 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. PRIOR MEDICATION: Excluded at any time: Prior TMP/SMX as primary PCP prophylaxis. Excluded within 4 weeks prior to study entry: 1. Initiation of antiretroviral agents. 2. Initiation of anti-infective agents (including TMP/SMX for another indication). Excluded within 2 weeks prior to study entry: 1. Antihistamines. 2. Procysteine. 3. Glutathione. 4. N-acetylcysteine (NAC). 5. Systemic corticosteroids (unless used for replacement purposes). 6. Leucovorin calcium. 7. TMP and sulfa drugs separately. CONCURRENT MEDICATION: Excluded: 1. Procysteine. 2. Glutathione. 3. N-acetylcysteine (NAC). 4. Antihistamines (unless used for symptomatic treatment of study drug toxicity). 5. Systemic corticosteroids (unless used for replacement purposes). 6. Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity). 7. TMP or sulfa drugs outside of the study. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Known adverse reactions to sulfa, trimethoprim, or TMP/SMX. 2. Inability to comply with dosing schedule or complete dosing record. GENERIC DRUG NAME ----------------- Drug 1: Trimethoprim. Antibacterial agent. Drug 2: Sulfamethoxazole. Antibacterial agent. DRUG TRADE NAME --------------- Drug 1: Septra (in combination with sulfamethoxazole). Drug 2: Septra (in combination with trimethoprim). DRUG COMPANIES -------------- Drug 1: Burroughs Wellcome 3030 Cornwallis Road Research Triangle, NC 27709 Contact: Drug Information (800) 443-6763. Drug 2: Burroughs Wellcome 3030 Cornwallis Road Research Triangle, NC 27709 Contact: Drug Information (800) 443-6763. END POINT --------- Development of treatment-limiting adverse effects. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Unacceptable toxicity. 2. Development of an intercurrent illness such as major opportunistic infection, new AIDS-defining illness, generalized debilitation, or mental incapacity that would preclude informed consent. 3. Futher participation deemed detrimental to patient's health or well-being. 4. Patient noncompliance or request of patient to withdraw from treatment. PARTICIPATING UNITS ------------------- 0000001357: Johns Hopkins University / Infectious Diseases 1830 East Monument Street Room 8071 Baltimore, MD 21205 Contact: Becky Becker (410) 955-2898 OPEN 941123 ACTU: 0201. 0000001432: State of Maryland Div of Corrections c/o Johns Hopkins Hosp 1830 East Monument Street / Room 8071 Baltimore, MD 21205 Contact: Becky Becker (410) 955-2898 OPEN 941123 ACTU: 0202. 0000001335: Washington University School of Medicine 4511 Forest Park Pkwy Suite 304 St Louis, MO 63108 Contact: Michael Klebert (314) 454-0538 Contact: (314) 454-0058 OPEN 941130 ACTU: 2101. 0000001336: St Louis Regional Hospital 5535 Del Mar / 6Th Floor West Annex St Louis, MO 63112 Contact: Michael Conklin (314) 879-6411 OPEN 941130 ACTU: 2102. 0000001334: SUNY at Buffalo 462 Grider Street / BB109 Buffalo, NY 14215 Contact: Michelle Lewis (716) 898-3932 Contact: (716) 898-3933 OPEN 941130 ACTU: 1102. 0000001307: Ohio State University Hospital Clinic 456 West 10th Avenue / Room 4725 Columbus, OH 43210-1228 Contact: Judy Neidig (614) 293-8112 Contact: (614) 293-5282 OPEN 941123 ACTU: 2301. *************************************************************************