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HIV InfectionPhase 3NCT00094367

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)

A Phase 3 study testing Abacavir/Lamivudine in people with HIV Infection, run by GlaxoSmithKline at 178 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
Abacavir/Lamivudine
How many people
900 participants
Where
178 sitesUnited States
Study dates
Jul 2004to Oct 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

178 sites in 1 country.

178 sites in 1 country

United States178 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Annandale, Virginia, 22003

  • GSK Investigational Site

    Arleta, California, 91331

  • GSK Investigational Site

    Arlington, Texas, 76015

  • GSK Investigational Site

    Atlanta, Georgia, 30308/30309

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Atlanta, Georgia, 30312

  • GSK Investigational Site

    Atlanta, Georgia, 30318

  • GSK Investigational Site

    Atlanta, Georgia, 30329

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austell, Georgia, 30106

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Baltimore, Maryland, 21209

  • GSK Investigational Site

    Baltimore, Maryland, 21218

  • GSK Investigational Site

    Baltimore, Maryland, 21229-5299

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70816

  • GSK Investigational Site

    Berkeley, Michigan, 48072

  • GSK Investigational Site

    Bethesda, Maryland, 20816

  • GSK Investigational Site

    Beverly Hills, California, 90210

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Boise, Idaho, 83704

  • GSK Investigational Site

    Brooklyn, New York, 11201

  • GSK Investigational Site

    Brooklyn, New York, 11212

  • GSK Investigational Site

    Brooklyn, New York, 11215

  • GSK Investigational Site

    Brooklyn, New York, 11220

  • GSK Investigational Site

    Brooklyn, New York, 11237

  • GSK Investigational Site

    Charlotte, North Carolina, 28211

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Chicago, Illinois, 60643

  • GSK Investigational Site

    Cleveland, Ohio, 44109

  • GSK Investigational Site

    Clinton, Maryland, 20735

  • GSK Investigational Site

    Columbia, Missouri, 65212

  • GSK Investigational Site

    Columbus, Georgia, 31906

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Coral Springs, Florida, 33065

  • GSK Investigational Site

    Dallas, Texas, 75219

  • GSK Investigational Site

    Dallas, Texas, 75235

  • GSK Investigational Site

    Danville, Pennsylvania, 17822

  • GSK Investigational Site

    Daytona Beach, Florida, 32114

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Denver, Colorado, 80204

  • GSK Investigational Site

    Denver, Colorado, 80205

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Des Moines, Iowa, 50309-1426

  • GSK Investigational Site

    East Orange, New Jersey, 07017

  • GSK Investigational Site

    El Paso, Texas, 79905

  • GSK Investigational Site

    Elgin, Illinois, 60120

  • GSK Investigational Site

    Englewood, New Jersey, 07631

  • GSK Investigational Site

    Fairfax, Virginia, 22030

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33145

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33308

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fort Myers, Florida, 33901

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gainesville, Florida, 32601

  • GSK Investigational Site

    Galloway, New Jersey, 08205

  • GSK Investigational Site

    Galveston, Texas, 77555-0188

  • GSK Investigational Site

    Glastonbury, Connecticut, 06033

  • GSK Investigational Site

    Glendale, Arizona, 85306

  • GSK Investigational Site

    Grand Rapids, Michigan, 49503

  • GSK Investigational Site

    Great Neck, New York, 10020

  • GSK Investigational Site

    Greenville, South Carolina, 29605

  • GSK Investigational Site

    Henderson, Kentucky, 42420

  • GSK Investigational Site

    Henderson, Nevada, 89015

  • GSK Investigational Site

    Hoboken, New Jersey, 07030

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Houston, Texas, 77009

  • GSK Investigational Site

    Houston, Texas, 77027

  • GSK Investigational Site

    Houston, Texas, 77098

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Indianapolis, Indiana, 46204

  • GSK Investigational Site

    Inmokalee, Florida, 34142

  • GSK Investigational Site

    Jersey City, New Jersey, 07304

  • GSK Investigational Site

    Jersey City, New Jersey, 07306

  • GSK Investigational Site

    Johnson City, Tennessee, 37614

  • GSK Investigational Site

    Joliet, Illinois, 60432

  • GSK Investigational Site

    Kansas City, Missouri, 64112

  • GSK Investigational Site

    Kansas City, Missouri, 64132

  • GSK Investigational Site

    Key West, Florida, 33040

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    Las Vegas, Nevada, 79102

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Long Beach, California, 90801

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Longview, Texas, 75604

  • GSK Investigational Site

    Los Angeles, California, 90022

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Los Angeles, California, 90028

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Los Angeles, California, 90067

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Lowell, Massachusetts, 01854

  • GSK Investigational Site

    Manhasset, New York, 11030

  • GSK Investigational Site

    Melbourne, Florida, 32935

  • GSK Investigational Site

    Memphis, Tennessee, 38104

  • GSK Investigational Site

    Memphis, Tennessee, 38120

  • GSK Investigational Site

    Miami, Florida, 33133

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Miami Beach, Florida, 33139

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53212

  • GSK Investigational Site

    Montgomery, Alabama, 36105

  • GSK Investigational Site

    New Haven, Connecticut, 06520

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    New Orleans, Louisiana, 70117

  • GSK Investigational Site

    New Orleans, Louisiana, 70121

  • GSK Investigational Site

    New York, New York, 10003

  • GSK Investigational Site

    New York, New York, 10010

  • GSK Investigational Site

    New York, New York, 10011

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10019

  • GSK Investigational Site

    New York, New York, 10022

  • GSK Investigational Site

    New York, New York, 10025

  • GSK Investigational Site

    Newark, New Jersey, 07101-1709

  • GSK Investigational Site

    Newark, New Jersey, 07102

  • GSK Investigational Site

    Newark, New Jersey, 07112

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    North Miami, Florida, 33161

  • GSK Investigational Site

    Norwalk, Connecticut, 06851

  • GSK Investigational Site

    Oakland, California, 94602

  • GSK Investigational Site

    Oakland, California, 94609

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Pampano, Florida, 33062

  • GSK Investigational Site

    Panorama City, California, 91402

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Pembroke Pines, Florida, 33024

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19103

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19121

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19131

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19143

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19146

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Phoenix, Arizona, 85015

  • GSK Investigational Site

    Plantation, Florida, 33317

  • GSK Investigational Site

    Pompano Beach, Florida, 33062

  • GSK Investigational Site

    Port Saint Lucie, Florida, 34952

  • GSK Investigational Site

    Portland, Oregon, 97209

  • GSK Investigational Site

    Reading, Pennsylvania, 19601

  • GSK Investigational Site

    Richmond, Virginia, 23224

  • GSK Investigational Site

    Riverdale, Georgia, 30274

  • GSK Investigational Site

    Riverside, California, 92507

  • GSK Investigational Site

    Saint Louis, Michigan, 63117

  • GSK Investigational Site

    Salinas, California, 93912

  • GSK Investigational Site

    Salt Lake City, Utah, 84132

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Francisco, California, 94102

  • GSK Investigational Site

    San Francisco, California, 94114

  • GSK Investigational Site

    Santa Fe, New Mexico, 87505

  • GSK Investigational Site

    Santa Rosa, California, 95404

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    Silver Spring, Maryland, 20910

  • GSK Investigational Site

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    South Miami, Florida, 33143

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Springfield, Massachusetts, 01107

  • GSK Investigational Site

    St. Petersburg, Florida, 33710

  • GSK Investigational Site

    Stamford, Connecticut, 06902

  • GSK Investigational Site

    Staten Island, New York, 10304

  • GSK Investigational Site

    Stratford, Connecticut, 06614

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Tamarac, Florida, 33321

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Tarzana, California, 30342

  • GSK Investigational Site

    Tarzana, California, 91356

  • GSK Investigational Site

    The Bronx, New York, 10457

  • GSK Investigational Site

    Tucson, Arizona, 85745

  • GSK Investigational Site

    Tyler, Texas, 75708

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    West Palm Beach, Florida, 33408

  • GSK Investigational Site

    Westfield, New Jersey, 07090

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV Infection
Being tested
Abacavir/Lamivudine
Keywords
1592U89, GR109714, abacavir, lamivudine, fixed-dose combination, once-daily, twice-daily, HIV infection, naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abacavir/LamivudineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

  1. occurrence of abacavir HSR

  2. completion of educational training

  3. subject satisfaction with treatment

  4. adherence to study medications

  5. change in HIV-1 RNA from BL

  6. change in CD4 measure from BL.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionOct 2005
  4. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00094367
Sponsor's protocol ID
101822
Status last verified
Sep 2010
First submitted
16 Oct 2004
Last updated
30 Sep 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abacavir/Lamivudine in people with HIV Infection, run by GlaxoSmithKline at 178 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of treatment-limiting adverse events after starting study drugs.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094367.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2010.

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