A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Zidovudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: Aerosolized pentamidine (300 mg every 4 weeks). Allowed: Chronic suppressive treatment for toxoplasmosis, Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis, herpes simplex virus infection. Ganciclovir for patients developing cytomegalovirus (CMV) infection while in study. Erythropoietin for patients under the relevant treatment IND. Treatment of opportunistic infections with other than sulfonamide-containing regimens. Aspirin, acetaminophen, or non-steroidal anti-inflammatory agents is discouraged, but is permitted for as short a period of time as possible. Chronic use of trimethoprim - sulfamethoxazole or other sulfonamide preparations is not encouraged while on study. Patients must: Have had the diagnosis of AIDS or advanced AIDS related complex (ARC). Have received AZT therapy for at least 12 months, with a minimal daily dose of 500 mg/day and with no more than 60 days off AZT therapy within the 12 month period; medical records with documentation of AZT dosing must be provided. Provide informed consent (guardian as appropriate). Be available for follow-up for at least 6 months. Have the inclusion laboratory values within approximately 14 days of initiating therapy (except for CD4 cell counts). Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts < 300 cells/mm3. Allowed: Positive blood culture for Mycobacterium avium or Cytomegalovirus. Prior history of toxoplasmosis, Herpes simplex, Cryptococcus, or Pneumocystis carinii pneumonia (PCP) requiring chronic suppressive therapy. Occasional premature atrial or ventricular contractions. Prior Medication: Required: Zidovudine (AZT) therapy for at least 12 months, with a minimal daily dose of 500 mg/day, and with no more than 60 days off AZT therapy within the 12-month period (documentation of AZT dosing must be provided). Allowed: Intralesional agents. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy. AIDS-dementia complex = or > stage 2. Active AIDS defining opportunistic infections not specifically allowed. Intractable diarrhea. Grade 2 neuropathy, based on the Neuropathy Targeted Symptom Questionnaire, or any moderate abnormality indicative of peripheral neuropathy, particularly impaired sensation of sharp pain, light touch, or vibration in the lower extremities, distal extremity weakness, or distal extremity hyperreflexia. Prior history of acute pancreatitis within past 2 years or chronic pancreatitis. History of seizures within past 2 years or currently requiring anticonvulsants for control. History of past or current heart disease. Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial. Life expectancy < 3 months. Concurrent Medication: Excluded: Isoniazid (INH). Neurotoxic drugs. Oral acidifying agents. Patients with the following are excluded: Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy. AIDS-dementia complex = or > stage 2. Active AIDS defining opportunistic infections not specifically allowed. Intractable diarrhea. Prior history of acute pancreatitis within past 2 years or chronic pancreatitis. History of seizures within past 2 years or currently requiring anticonvulsants for control. History of past or current heart disease. Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial. Life expectancy = or < 3 months. Previous participation in any study of ddI, ddC or d4T. Prior Medication: Excluded: Ganciclovir (DHPG). Excluded within 1 month of study entry: ddI and any other antiretroviral drug or investigational anti-HIV agent except for zidovudine (AZT). Interferons. Immunomodulating drugs. Cytotoxic agents not specifically allowed. Neurotoxic drugs. Excluded within 3 months of study entry: Ribavirin. Prior Treatment: Excluded within 14 days of study randomization: Blood transfusion. Active alcohol or drug abuse that is sufficient, in investigator's opinion, to prevent adequate compliance with study therapy.
Sites / Locations
- Children's Hosp of Los Angeles/UCLA Med Ctr
- Los Angeles County - USC Med Ctr
- Cedars Sinai / UCLA Med Ctr
- UCLA CARE Ctr
- Harbor - UCLA Med Ctr / UCLA School of Medicine
- Palo Alto Veterans Adm Med Ctr / Stanford Univ
- Univ of California / San Diego Treatment Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Stanford Univ School of Medicine
- Olive View Med Ctr
- Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
- Harbor UCLA Med Ctr
- Mountain States Regional Hemophilia Ctr / Univ of Colorado
- Univ of Colorado Health Sciences Ctr
- George Washington Univ Med Ctr
- G E Morey Jr
- Univ of Miami School of Medicine
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- Edward Hines Veterans Administration Hosp
- Indiana Univ Hosp
- Univ of Kansas School of Medicine
- Louisiana Comprehensive Hemophilia Care Ctr
- Louisiana State Univ Med Ctr / Tulane Med School
- Tulane Univ School of Medicine
- Harvard (Massachusetts Gen Hosp)
- Boston Med Ctr
- Beth Israel Deaconess - West Campus
- Beth Israel Deaconess Med Ctr
- Baystate Med Ctr of Springfield
- Med Ctr of Central Massachusetts
- Univ of Massachusetts Med Ctr
- Univ of Minnesota
- Nebraska Regional Hemophilia Ctr
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- Bronx Veterans Administration / Mount Sinai Hosp
- SUNY / Erie County Med Ctr at Buffalo
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
- Beth Israel Med Ctr / Peter Krueger Clinic
- Bellevue Hosp / New York Univ Med Ctr
- Cornell Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Hemophilia Ctr / Mount Sinai Med Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- SUNY - Stony Brook
- SUNY / State Univ of New York
- Univ of North Carolina
- Duke Univ Med Ctr
- Bowman Gray School of Medicine / Wake Forest Univ
- Holmes Hosp / Univ of Cincinnati Med Ctr
- Univ Hosp of Cleveland / Case Western Reserve Univ
- Ohio State Univ Hosp Clinic
- Med College of Ohio
- Milton S Hershey Med Ctr
- Univ of Pennsylvania
- Hemophilia Ctr of Western PA / Univ of Pittsburgh
- Univ of Pittsburgh Med School
- Julio Arroyo
- Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
- Hermann Hosp / Univ Texas Health Science Ctr
- Dr Stephen L Green
- Univ of Washington
- Dr Brian Buggy
- Milwaukee County Med Complex
- Great Lakes Hemophilia Foundation
- San Juan Veterans Administration Med Ctr