A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Nevirapine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis. Allowed: Erythropoietin maintenance. G-CSF and GM-CSF. Prophylaxis for Mycobacterium avium intracellulare. Antifungal prophylaxis or treatment with specific drugs. Maintenance therapy for opportunistic infection. Over-the-counter medications or alternative therapies such as vitamins and herbs. Antibiotics as clinically indicated. Steroids for < 21 days for acute problems. Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications. Concurrent Treatment: Allowed: Radiation therapy for cutaneous Kaposi's sarcoma. Acupuncture. Patients must have: Documented HIV infection. CD4 count <= 50 cells/mm3. Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance. Life expectancy of at least 6 months. Consent of parent or guardian if < 18 years of age. Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment). NOTE: Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Abnormal baseline chest x-ray. New pulmonary or cardiac symptoms. Psychological or emotional problems sufficient to prevent compliance with study medication. Concurrent Medication: Excluded: Systemic chemotherapy for malignancy. Acute or induction therapy for opportunistic infection. Antiretroviral drugs other than study drugs. Biological response modifiers. Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin. Patients with the following prior conditions are excluded: History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. Evidence of active pulmonary disease within 6 months prior to study entry. History of grade 3 or worse peripheral neuropathy. History of acute or chronic pancreatitis. Prior Medication: Excluded: Prior nevirapine. Excluded within 7 days prior to study entry: Acute therapy for opportunistic infection (maintenance therapy is permitted). Acute systemic therapy for a nonopportunistic infection or other medical condition. Antiretroviral drugs other than AZT, ddI, or ddC. Biological response modifiers. d4T therapy. Nucleosides other than those used in the study. Antibiotics containing clavulanate potassium. Prior Treatment: Excluded: More than 4 units of blood in a 30-day period. Active alcohol or drug abuse.
Sites / Locations
- Univ of Alabama at Birmingham
- Children's Hosp of Los Angeles
- Univ of Southern California / LA County USC Med Ctr
- Huntington Memorial Hosp / Children's Hosp of Los Angeles
- Univ of California / San Diego Treatment Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
- San Mateo AIDS Program / Stanford Univ
- Stanford Univ Med Ctr
- Olive View Med Ctr
- Harbor UCLA Med Ctr
- Denver Dept of Health and Hosps
- Mountain States Reg Hemo Ctr / Univ of Colorado
- Rose Med Ctr
- Univ of Colorado Health Sciences Ctr
- Yale Univ / New Haven
- HIV Ctr - District of Columbia Gen Hosp
- Whitman - Walker Clinic / Georgetown Univ Med Ctr
- Georgetown Univ Med Ctr
- George Washington Univ / Hershey Med Ctr
- Howard Univ
- Univ of Miami School of Medicine
- Univ of South Florida
- Univ of Hawaii
- Northwestern Univ Med School
- Cook County Hosp
- Rush Presbyterian - Saint Luke's Med Ctr
- Louis A Weiss Memorial Hosp
- Indiana Univ Hosp
- Methodist Hosp of Indiana / Life Care Clinic
- Univ of Louisville / East Tennesee Comprehensive Hem Ctr
- Harvard (Massachusetts Gen Hosp)
- Boston Med Ctr
- Beth Israel Deaconess - West Campus
- Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
- Hennepin County Med Clinic
- Univ of Minnesota
- St Paul Ramsey Med Ctr
- St Louis Regional Hosp / St Louis Regional Med Ctr
- Univ of Nebraska Med Ctr
- Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
- Robert Wood Johnson Med School / Hershey Med Ctr
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
- Adirondack Med Ctr at Saranac Lake
- Albany Med College / Division of HIV Medicine A158
- Mid - Hudson Care Ctr
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Comprehensive Health Care Ctr / Bronx Municipal Hosp
- Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
- Montefiore Family Health Ctr / Bronx Municipal Hosp
- Samaritan Village Inc / Bronx Municipal Hosp
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- Montefiore Med Ctr Adolescent AIDS Program
- North Central Bronx Hosp / Bronx Municipal Hosp
- Bronx Veterans Administration / Mount Sinai Hosp
- SUNY / Health Sciences Ctr at Brooklyn
- SUNY / Erie County Med Ctr at Buffalo
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
- North Shore Univ Hosp
- Beth Israel Med Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Saint Clare's Hosp and Health Ctr
- Cornell Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Mount Sinai Med Ctr / Hemophilia Treatment Ctr
- Mount Sinai Med Ctr
- Columbia Presbyterian Med Ctr
- Harlem Hosp Ctr
- Univ of Rochester Medical Center
- SUNY / State Univ of New York
- Univ of North Carolina
- Moses H Cone Memorial Hosp
- Univ of Cincinnati
- Univ of Kentucky Lexington
- Case Western Reserve Univ
- MetroHealth Med Ctr
- Columbus Children's Hosp
- Med College of Ohio
- Milton S Hershey Med Ctr
- Saint Michael's Med Ctr / Milton S Hershey Med Ctr
- Girard Med Ctr
- Univ of Pennsylvania at Philadelphia
- Thomas Jefferson Univ Hosp
- Med Univ of South Carolina / UNC
- Julio Arroyo
- Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
- Meharry Med College
- Univ of Texas Galveston
- Univ Texas Health Science Ctr / Univ Texas Med School
- Univ of Washington
- Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
- Great Lakes Hemophilia Foundation
- Univ of Puerto Rico