A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Completed · Phase 3

Conditions studied: HIV Infections

In brief

To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. 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.

Key facts

Study ID

NCT00000637

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

819

Expected to finish

1996-09-01

Last updated by the study team

2021-11-02

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Kaiser Permanente / UCLA Med Ctr — Downey, California, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Cedars Sinai / UCLA Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Children's Hosp of Oakland — Oakland, California, United States
• Huntington Memorial Hosp / Children's Hosp of Los Angeles — Pasadena, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Stanford Univ School of Medicine / Pediatrics — Stanford, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Univ of Connecticut Health Ctr — Farmington, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Univ of Alabama at Birmingham Schl of Med / Pediatrics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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