Completed

Interaction Between 1592U89 and Ethanol in HIV-Infected Subjects

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Abacavir sulfate

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 18 to 55 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002198
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

6 inclusion criteria required to participate
CD4+ lymphocyte count >= 200 cells/microliter within 14 days prior to study drug administration

HIV-1 infection

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

Local treatment for Kaposi's sarcoma

Show More Criteria

18 exclusion criteria prevent from participating
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

Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

PPD Development, Inc

Wilmington, United StatesOpen PPD Development, Inc in Google Maps
CompletedOne Study Center