A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine
Didanosine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important. Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 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 18 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: Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP). Immunoglobulin. Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week. Concurrent Treatment: Allowed: Blood transfusions. Prior Medication: Allowed: Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP). Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study. Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144. Patient or guardian available to give written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded. Hypersensitivity to didanosine (ddI). Symptomatic cardiomyopathy. Seizures that are not well controlled by ongoing anticonvulsant therapy. Symptomatic pancreatitis. Grade 1 or higher peripheral neuropathy. Active malignancy requiring chemotherapy. Concurrent Medication: Excluded: Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications. Avoid: Drugs with potential to cause peripheral neuropathy or pancreatitis. Patients with the following are excluded: Active malignancy requiring concomitant chemotherapy. Prior Medication: Excluded: Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry. Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry. Any other experimental therapy within 1 week of entry. Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.
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 52 locations
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, United StatesOpen Long Beach Memorial Med. Ctr., Miller Children's Hosp. in Google MapsUsc La Nichd Crs
Los Angeles, United StatesUCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, United StatesChildren's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, United States