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)

September 29, 2010 updated by: GlaxoSmithKline

See Detailed Description

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.

Study Type

Interventional

Enrollment

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36105
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85015
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85745
        • GSK Investigational Site
    • California
      • Arleta, California, United States, 91331
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90211
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Long Beach, California, United States, 90813
        • GSK Investigational Site
      • Long Beach, California, United States, 90801
        • GSK Investigational Site
      • Los Angeles, California, United States, 90022
        • GSK Investigational Site
      • Los Angeles, California, United States, 90027
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Los Angeles, California, United States, 90067
        • GSK Investigational Site
      • Los Angeles, California, United States, 90028
        • GSK Investigational Site
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
      • Oakland, California, United States, 94609
        • GSK Investigational Site
      • Oakland, California, United States, 94602
        • GSK Investigational Site
      • Palm Springs, California, United States, 92262
        • GSK Investigational Site
      • Panorama City, California, United States, 91402
        • GSK Investigational Site
      • Paramount, California, United States, 90723
        • GSK Investigational Site
      • Riverside, California, United States, 92507
        • GSK Investigational Site
      • Salinas, California, United States, 93912
        • GSK Investigational Site
      • San Francisco, California, United States, 94102
        • GSK Investigational Site
      • San Francisco, California, United States, 94114
        • GSK Investigational Site
      • Santa Rosa, California, United States, 95404
        • GSK Investigational Site
      • Tarzana, California, United States, 91356
        • GSK Investigational Site
      • Tarzana, California, United States, 30342
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
      • Denver, Colorado, United States, 80204
        • GSK Investigational Site
      • Denver, Colorado, United States, 80205
        • GSK Investigational Site
    • Connecticut
      • Glastonbury, Connecticut, United States, 06033
        • GSK Investigational Site
      • New Haven, Connecticut, United States, 06520
        • GSK Investigational Site
      • Norwalk, Connecticut, United States, 06851
        • GSK Investigational Site
      • Stamford, Connecticut, United States, 06902
        • GSK Investigational Site
      • Stratford, Connecticut, United States, 06614
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • GSK Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
      • Coral Springs, Florida, United States, 33065
        • GSK Investigational Site
      • Daytona Beach, Florida, United States, 32114
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33145
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33901
        • GSK Investigational Site
      • Gainesville, Florida, United States, 32601
        • GSK Investigational Site
      • Inmokalee, Florida, United States, 34142
        • GSK Investigational Site
      • Key West, Florida, United States, 33040
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32935
        • GSK Investigational Site
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
      • Miami, Florida, United States, 33133
        • GSK Investigational Site
      • Miami Beach, Florida, United States, 33139
        • GSK Investigational Site
      • North Miami, Florida, United States, 33161
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Orlando, Florida, United States, 32803
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Pampano, Florida, United States, 33062
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • GSK Investigational Site
      • Plantation, Florida, United States, 33317
        • GSK Investigational Site
      • Pompano Beach, Florida, United States, 33062
        • GSK Investigational Site
      • Port St. Lucie, Florida, United States, 34952
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34239
        • GSK Investigational Site
      • South Miami, Florida, United States, 33143
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33710
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
      • Tamarac, Florida, United States, 33321
        • GSK Investigational Site
      • Tampa, Florida, United States, 33614
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33408
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30309
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30312
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30318
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30329
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30308/30309
        • GSK Investigational Site
      • Austell, Georgia, United States, 30106
        • GSK Investigational Site
      • Columbus, Georgia, United States, 31906
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Riverdale, Georgia, United States, 30274
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60643
        • GSK Investigational Site
      • Elgin, Illinois, United States, 60120
        • GSK Investigational Site
      • Joliet, Illinois, United States, 60432
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46204
        • GSK Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309-1426
        • GSK Investigational Site
    • Kentucky
      • Henderson, Kentucky, United States, 42420
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40202
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70816
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70117
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21209
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21218
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21229-5299
        • GSK Investigational Site
      • Bethesda, Maryland, United States, 20816
        • GSK Investigational Site
      • Clinton, Maryland, United States, 20735
        • GSK Investigational Site
      • Silver Spring, Maryland, United States, 20910
        • GSK Investigational Site
    • Massachusetts
      • Lowell, Massachusetts, United States, 01854
        • GSK Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • GSK Investigational Site
    • Michigan
      • Berkeley, Michigan, United States, 48072
        • GSK Investigational Site
      • Grand Rapids, Michigan, United States, 49503
        • GSK Investigational Site
      • Lansing, Michigan, United States, 48910
        • GSK Investigational Site
      • St. Louis, Michigan, United States, 63117
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • GSK Investigational Site
      • Columbia, Missouri, United States, 65212
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64132
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64112
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89015
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 79102
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • New Jersey
      • East Orange, New Jersey, United States, 07017
        • GSK Investigational Site
      • Englewood, New Jersey, United States, 07631
        • GSK Investigational Site
      • Galloway, New Jersey, United States, 08205
        • GSK Investigational Site
      • Hoboken, New Jersey, United States, 07030
        • GSK Investigational Site
      • Jersey City, New Jersey, United States, 07304
        • GSK Investigational Site
      • Jersey City, New Jersey, United States, 07306
        • GSK Investigational Site
      • Newark, New Jersey, United States, 07102
        • GSK Investigational Site
      • Newark, New Jersey, United States, 07112
        • GSK Investigational Site
      • Newark, New Jersey, United States, 07101-1709
        • GSK Investigational Site
      • Somers Point, New Jersey, United States, 08244
        • GSK Investigational Site
      • Westfield, New Jersey, United States, 07090
        • GSK Investigational Site
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • GSK Investigational Site
      • Bronx, New York, United States, 10457
        • GSK Investigational Site
      • Brooklyn, New York, United States, 11201
        • GSK Investigational Site
      • Brooklyn, New York, United States, 11215
        • GSK Investigational Site
      • Brooklyn, New York, United States, 11212
        • GSK Investigational Site
      • Brooklyn, New York, United States, 11220
        • GSK Investigational Site
      • Brooklyn, New York, United States, 11237
        • GSK Investigational Site
      • Great Neck, New York, United States, 10020
        • GSK Investigational Site
      • Manhasset, New York, United States, 11030
        • GSK Investigational Site
      • New York, New York, United States, 10022
        • GSK Investigational Site
      • New York, New York, United States, 10025
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • New York, New York, United States, 10003
        • GSK Investigational Site
      • New York, New York, United States, 10011
        • GSK Investigational Site
      • New York, New York, United States, 10019
        • GSK Investigational Site
      • New York, New York, United States, 10010
        • GSK Investigational Site
      • Staten Island, New York, United States, 10304
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • GSK Investigational Site
      • Huntersville, North Carolina, United States, 28078
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97209
        • GSK Investigational Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19146
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19131
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19143
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19103
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19121
        • GSK Investigational Site
      • Reading, Pennsylvania, United States, 19601
        • GSK Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37614
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38120
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38104
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76015
        • GSK Investigational Site
      • Austin, Texas, United States, 78705
        • GSK Investigational Site
      • Dallas, Texas, United States, 75235
        • GSK Investigational Site
      • Dallas, Texas, United States, 75219
        • GSK Investigational Site
      • El Paso, Texas, United States, 79905
        • GSK Investigational Site
      • Galveston, Texas, United States, 77555-0188
        • GSK Investigational Site
      • Houston, Texas, United States, 77027
        • GSK Investigational Site
      • Houston, Texas, United States, 77004
        • GSK Investigational Site
      • Houston, Texas, United States, 77098
        • GSK Investigational Site
      • Houston, Texas, United States, 77009
        • GSK Investigational Site
      • Longview, Texas, United States, 75604
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • Tyler, Texas, United States, 75708
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • GSK Investigational Site
    • Virginia
      • Annandale, Virginia, United States, 22003
        • GSK Investigational Site
      • Fairfax, Virginia, United States, 22030
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23224
        • GSK Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53212
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The occurrence of treatment-limiting adverse events after starting study drugs.

Secondary Outcome Measures

Outcome Measure
occurrence of abacavir HSR
completion of educational training
subject satisfaction with treatment
adherence to study medications
change in HIV-1 RNA from BL
change in CD4 measure from BL.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, PharmD, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

October 16, 2004

First Submitted That Met QC Criteria

October 16, 2004

First Posted (Estimate)

October 18, 2004

Study Record Updates

Last Update Posted (Estimate)

September 30, 2010

Last Update Submitted That Met QC Criteria

September 29, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101822

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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