A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
Zidovudine
+ Didanosine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children. Patients are placed by random selection into one of three groups to receive either AZT alone, ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating physician knows which group patient is in. If patients are receiving either AZT or ddI alone and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the alternative single drug is offered. If patients receiving both drugs develop drug toxicity (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted. Patients who reach crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently discontinued from study drugs.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.819 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 3 Months to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Concurrent Medication: Allowed: Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for > 72 hours. Systemic ketoconazole and fluconazole for acute therapy. Recommended: Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis. Patients must have the following: HIV infection. Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted. Prior Medication: Allowed: Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active malignancy. Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. History of uncontrolled seizure disorder. Grade 3 or higher peripheral neuropathy. Cardiomyopathy. Concurrent Medication: Excluded: Chemotherapy for malignancy. Oral acidifying agents. Acetaminophen, ibuprofen, or aspirin on a continual basis for > 72 hours. Ketoconazole or fluconazole for prophylaxis. Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for > 4 weeks. Patients with the following are excluded: Active malignancy. Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. History of uncontrolled seizure disorder. Grade 3 or higher peripheral neuropathy. Prior Medication: Excluded: Steroids. Intravenous immunoglobulin. Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for > 6 weeks and within 7 days prior to study entry. Prior Treatment: Excluded: Red blood cell transfusion within four weeks prior to study entry. Ongoing drug or alcohol use.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 80 locations
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, United StatesOpen Univ of Alabama at Birmingham Schl of Med / Pediatrics in Google MapsKaiser Permanente / UCLA Med Ctr
Downey, United StatesUCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesLong Beach Memorial (Pediatric)
Long Beach, United States