The Safety and Effectiveness of 935U83 in HIV-Infected Patients

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Recommended:
• • PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.
• Allowed:
• • Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
• Patients must have:
• • HIV infection.
• • CD4 count 200 - 500 cells/mm3.
• • No history of or current AIDS-defining indicator disease by CDC criteria.
• • No antiretroviral therapy within the past 6 months.
• • Consent of parent or guardian if less than 18 years of age.
• • Exclusion Criteria
• Co-existing Condition:
• Patient with the following symptoms or conditions are excluded:
• • Current evidence of chronic hepatitis of any etiology.
• • Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
• Concurrent Medication:
• Excluded:
• • Cytotoxic chemotherapy.
• • Other antiretroviral drugs.
• • Immunomodulators.
• • Foscarnet.
• • GM-CSF or G-CSF.
• • Erythropoietin.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy.
• Patients with the following prior conditions are excluded:
• • History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.
• Prior Medication:
• Excluded within the past 6 months:
• • Any antiretroviral therapy.
• • HIV immunotherapeutic vaccine.
• Excluded within the past 4 weeks:
• • Cytotoxic chemotherapy.
• • Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.
• Prior Treatment:
• Excluded within the past 4 weeks:
• • Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.