The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.

In part 1, patients will receive 1592U89 monotherapy for 12 weeks. Patients will be assigned initially to a low dose of 1592U89 (Dose A). Those patients who tolerate the drug for at least six weeks without a toxicity of grade 3 or above attribu...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • IVIG.
• • Erythropoietin, granulocyte colony stimulating factor and granulocyte macrophage colony stimulating factor (for management of hematologic toxicity).
• Patients must have:
• • Documented HIV-1 infection.
• • Laboratory evidence of immunosuppression or symptomatic HIV disease.
• • Parent or legal guardian able and willing to provide signed informed consent.
• Prior Medication: Required:
• • HIV infected infants and children will be eligible for the trial if they have received greater than 56 days of previous antiretroviral therapy.
• NOTE:
• • Those children who participated in the single dose phase I study of 1592U89 and satisfy all other criteria for inclusion may have received \<= 56 days of previous antiretroviral therapy.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Grade 3 or greater abnormalities in any toxicity monitoring laboratory tests at baseline.
• • Presence of an acute opportunistic infection requiring therapy at the time of enrollment.
• • Intractable or chronic diarrhea or vomiting.
• Concurrent Medication:
• Excluded:
• • Chemotherapy for active malignancy.
• • Concurrent use of antiretroviral agents other than those provided by the study, biologic response modifiers, human growth hormone, systemic corticosteroids (\>= 14 days duration), probenecid, I.V. pentamidine, immunomodulators (other than intravenous immunoglobulin), or other investigational drugs.
• Patients with any of the following prior conditions or symptoms are excluded:
• • - History of intolerance to any of the study drugs.