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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
The occurrence of treatment-limiting adverse events after starting study drugs.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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