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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002198
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Abacavir sulfate
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002198

Locations
United States, North Carolina
PPD Development, Inc
Wilmington, North Carolina, United States, 28412
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002198     History of Changes
Other Study ID Numbers: 238F, CNAA 1010
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Interactions
Antiviral Agents
Ethanol
abacavir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Abacavir
Ethanol
Anti-HIV Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Anti-Retroviral Agents
Antiviral Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014