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

June 23, 2005 updated by: Glaxo Wellcome

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28412
        • PPD Development, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

August 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 238F
  • CNAA 1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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