Expired Study
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Wilmington, North Carolina 28412


Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

238F


NCT ID:

NCT00002198


Secondary ID:

CNAA 1010


Study Acronym:


Brief Title:

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.


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:August 1997
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Abacavir sulfate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Glaxo Wellcome

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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