A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)

Completed · Phase 3

Conditions studied: HIV Infection

In brief

This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

Key facts

Study ID

NCT00094367

Run by

GlaxoSmithKline

People needed

900

Starts

2004-07-01

Expected to finish

2005-10-01

Last updated by the study team

2010-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have HIV-1 infection.
• Had not received any prior HIV treatment for more than 14 days.
• At least 1000 copies of HIV-1 RNA.
• Willing to provide signed informed consent.

You may not qualify if…

• Enrolled in other investigational drug studies.
• Female subjects who are pregnant or breastfeeding.
• History of allergy or hypersensitivity to abacavir or lamivudine.
• Certain medical conditions that would make subjects ineligible.

Where it is running

• GSK Investigational Site — Glendale, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Arleta, California, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Palm Springs, California, United States
• GSK Investigational Site — Panorama City, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Salinas, California, United States
• GSK Investigational Site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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