A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

Patients are randomized to one of the following three regimens:

Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3: 1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for 3 weeks.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Local treatment for Kaposi's sarcoma.
• • Prophylactic treatment for opportunistic infections.
• Patients must have:
• • HIV-1 infection.
• • CD4+ lymphocyte count \>= 200 cells/microliter within 14 days prior to study drug administration.
• • No active diagnosis of AIDS (other than visceral Kaposi's sarcoma) according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
• Prior Medication:
• Allowed:
• • Local treatment for Kaposi's sarcoma.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption.
• Concurrent Medication:
• Excluded:
• • Medications that cannot be withheld for 48 hours (24 hours for antiretrovirals) prior to study drug administration and until 12 hours after study drug administration on each dosing day.
• • Immunomodulators, such as systemic corticosteroids, interleukins and interferons.
• • Cytotoxic chemotherapeutic agents.
• • Acute treatment for opportunistic infections.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy.
• Patients with the following prior conditions are excluded:
• • Documented history of alcoholism.
• • History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
• • History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
• • Participation in another research study within the past month.
• Prior Medication:
• Excluded:
• • Cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
• • Immunomodulating agents within six weeks prior to study drug administration.
• * Treatment with the following within 2 weeks prior to study drug administration:
• • acyclovir, carbamazepine, chloramphenicol, ganciclovir, phenytoin, rifampin, sodium valproate, or valacyclovir.
• Prior Treatment:
• Excluded:
• • Radiation therapy within 6 weeks prior to study drug administration.
• • 1. Regular weekly alcohol intake of more than 21 units (a unit is equal to 1/2 pint beer or 1 glass of wine or 1 oz of liquor).
• • Recent change in normal pattern of alcohol usage (e.g., prolonged use followed by \> one month abstinence).
• • Total abstinence from alcohol use.
• • Positive breath alcohol test upon arrival at the study center prior to any dosing day.