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

HIV Infections Clinical Trial

Official title:

A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002198
• Other study ID #: 238F
• Secondary ID: CNAA 1010
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Abacavir sulfate

Locations

Country	Name	City	State
United States	PPD Development, Inc	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,