A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Local treatment for Kaposi's sarcoma.
• • GM-CSF, G-CSF or erythropoietin.
• Patients must have:
• • HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.
• • CD4+ cell count \>= 100 cells/mm3 within 14 days of study drug administration.
• • HIV-1 RNA \>= 5,000 copies/ml within 14 days of study drug administration.
• • No active or ongoing AIDS-defining opportunistic infection or disease.
• • Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
• Prior Medication:
• Allowed:
• • Local treatment for Kaposi's sarcoma.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.
• • Life-threatening infection or other serious medical condition that may compromise a patient's safety.
• Concurrent Medication:
• Excluded:
• * Other investigational agents. NOTE:
• • Those available through Treatment IND or expanded access programs are evaluated individually.
• • Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).
• • Agents with documented anti-HIV activity in vitro.
• • Foscarnet.
• • Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons.
• • Antioxidants.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy within the first 24 weeks of study.
• Patients with the following prior conditions are excluded:
• • History of clinically relevant pancreatitis or hepatitis within the last 6 months.
• • Participation in an investigational HIV-1 vaccine trial.
• Prior Medication:
• Excluded:
• • Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy.
• • Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
• • HIV-1 vaccine dose within the 3 months prior to study drug administration.
• • Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration.
• Prior Treatment:
• Excluded:
• • Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.