The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met, patients may have the option to switch to open-label treatment for the remainder of the study period.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Intravenous immunoglobulin G, erythropoietin, G-CSF and GM-CSF.
• • Opportunistic infection prophylaxis.
• Patients must have:
• * HIV-1 infection documented by:
• \< 18 months of age:
• • one positive viral test culture and one other positive viral test (culture, PCR, p24 antigen, or Immune Complex Dissociation p24 antigen) on two different specimens.
• \>= 18 months of age:
• • two positive viral tests as stated above, one or both of which may be determined by a federally documented ELISA and confirmed by Western blot or Indirect Fluorescent Antibody test.
• * Any of the CDC Categories:
• • 1, 2, 3, and N, A, B, and C of the 1994 Revised Classification System for HIV Infection in Children Less than 13 Years of Age.
• • CD4+ count \>= 15% within 14 days prior to study drug administration.
• • No active or ongoing AIDS-defining opportunistic infection that precludes absorption of study drug or observation of a study parameter.
• • Signed, informed consent from parent or legal guardian for patients under 18 years of age.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Serious bacterial infection that precludes absorption of study drug or observation of a study parameter.
• • Documented hypersensitivity to a nucleoside analog.
• • Co-enrollment in certain opportunistic infection protocols is not exclusionary if approval is obtained.
• • Malignancy.
• • Life-threatening infection or other chronic disease that may compromise patient safety.
• • Grade 3/4 clinical or laboratory toxicity or current grade 2 or higher pancreatic amylase or lipase toxicity as defined by the ACTG Toxicity Tables within 14 days prior to study entry.
• Concurrent Medication:
• Excluded:
• • Other anti-HIV therapy.
• • Probenecid.
• • Biologic response modifier (unless listed under included concurrent medication) and megestrol acetate.
• • Human growth hormone.
• • Immunomodulators and cytotoxic chemotherapeutic agents.
• • Systemic corticosteroids \> 14 days without approval.
• • Investigational agents.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy.
• Patients with the following prior conditions are excluded:
• • History of clinically relevant pancreatitis or hepatitis within the past 6 months.
• • Participation in a vaccine trial.
• Prior Medication:
• Excluded:
• • Protease inhibitor therapy within 2 weeks prior to randomization.
• • Interleukins or interferons within 30 days prior to study drug administration.
• • Investigational drugs within 14 days prior to randomization.
• • HIV vaccine dose within past 30 days.
• Required:
• • \> 12 weeks prior antiretroviral therapy and unchanged therapy 12 weeks prior to screening.