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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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002198 on ClinicalTrials.gov Archive Site
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A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
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.

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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Abacavir sulfate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002198
238F, CNAA 1010
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
August 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP