Clinical trial NCT00002198: A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
Official title: A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Drug Interactions
Antiviral Agents
Ethanol
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD Development, Inc
state: North Carolina
Study officials:
References: