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)
See Detailed Description
1 other identifier
interventional
900
1 country
178
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2004
Shorter than P25 for phase_3
178 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 16, 2004
CompletedFirst Posted
Study publicly available on registry
October 18, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedSeptember 30, 2010
September 1, 2010
1.3 years
October 16, 2004
September 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The occurrence of treatment-limiting adverse events after starting study drugs.
Secondary Outcomes (6)
occurrence of abacavir HSR
completion of educational training
subject satisfaction with treatment
adherence to study medications
change in HIV-1 RNA from BL
- +1 more secondary outcomes
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (178)
GSK Investigational Site
Montgomery, Alabama, 36105, United States
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Phoenix, Arizona, 85015, United States
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Arleta, California, 91331, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Beverly Hills, California, 90211, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Long Beach, California, 90801, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Long Beach, California, 90813, United States
GSK Investigational Site
Los Angeles, California, 90022, United States
GSK Investigational Site
Los Angeles, California, 90027, United States
GSK Investigational Site
Los Angeles, California, 90028, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90067, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Oakland, California, 94602, United States
GSK Investigational Site
Oakland, California, 94609, United States
GSK Investigational Site
Palm Springs, California, 92262, United States
GSK Investigational Site
Panorama City, California, 91402, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Riverside, California, 92507, United States
GSK Investigational Site
Salinas, California, 93912, United States
GSK Investigational Site
San Francisco, California, 94102, United States
GSK Investigational Site
San Francisco, California, 94114, United States
GSK Investigational Site
Santa Rosa, California, 95404, United States
GSK Investigational Site
Tarzana, California, 30342, United States
GSK Investigational Site
Tarzana, California, 91356, United States
GSK Investigational Site
Denver, Colorado, 80204, United States
GSK Investigational Site
Denver, Colorado, 80205, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
Glastonbury, Connecticut, 06033, United States
GSK Investigational Site
New Haven, Connecticut, 06520, United States
GSK Investigational Site
Norwalk, Connecticut, 06851, United States
GSK Investigational Site
Stamford, Connecticut, 06902, United States
GSK Investigational Site
Stratford, Connecticut, 06614, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Coral Springs, Florida, 33065, United States
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33145, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Fort Myers, Florida, 33901, United States
GSK Investigational Site
Gainesville, Florida, 32601, United States
GSK Investigational Site
Inmokalee, Florida, 34142, United States
GSK Investigational Site
Key West, Florida, 33040, United States
GSK Investigational Site
Melbourne, Florida, 32935, United States
GSK Investigational Site
Miami, Florida, 33133, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Miami Beach, Florida, 33139, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Pampano, Florida, 33062, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
Plantation, Florida, 33317, United States
GSK Investigational Site
Pompano Beach, Florida, 33062, United States
GSK Investigational Site
Port Saint Lucie, Florida, 34952, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
South Miami, Florida, 33143, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tamarac, Florida, 33321, United States
GSK Investigational Site
Tampa, Florida, 33614, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
West Palm Beach, Florida, 33408, United States
GSK Investigational Site
Atlanta, Georgia, 30308/30309, United States
GSK Investigational Site
Atlanta, Georgia, 30309, United States
GSK Investigational Site
Atlanta, Georgia, 30312, United States
GSK Investigational Site
Atlanta, Georgia, 30318, United States
GSK Investigational Site
Atlanta, Georgia, 30329, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Columbus, Georgia, 31906, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Riverdale, Georgia, 30274, United States
GSK Investigational Site
Boise, Idaho, 83704, United States
GSK Investigational Site
Chicago, Illinois, 60643, United States
GSK Investigational Site
Elgin, Illinois, 60120, United States
GSK Investigational Site
Joliet, Illinois, 60432, United States
GSK Investigational Site
Indianapolis, Indiana, 46204, United States
GSK Investigational Site
Des Moines, Iowa, 50309-1426, United States
GSK Investigational Site
Henderson, Kentucky, 42420, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70816, United States
GSK Investigational Site
New Orleans, Louisiana, 70115, United States
GSK Investigational Site
New Orleans, Louisiana, 70117, United States
GSK Investigational Site
New Orleans, Louisiana, 70121, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Baltimore, Maryland, 21209, United States
GSK Investigational Site
Baltimore, Maryland, 21218, United States
GSK Investigational Site
Baltimore, Maryland, 21229-5299, United States
GSK Investigational Site
Bethesda, Maryland, 20816, United States
GSK Investigational Site
Clinton, Maryland, 20735, United States
GSK Investigational Site
Silver Spring, Maryland, 20910, United States
GSK Investigational Site
Lowell, Massachusetts, 01854, United States
GSK Investigational Site
Springfield, Massachusetts, 01107, United States
GSK Investigational Site
Berkeley, Michigan, 48072, United States
GSK Investigational Site
Grand Rapids, Michigan, 49503, United States
GSK Investigational Site
Lansing, Michigan, 48910, United States
GSK Investigational Site
Saint Louis, Michigan, 63117, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Columbia, Missouri, 65212, United States
GSK Investigational Site
Kansas City, Missouri, 64112, United States
GSK Investigational Site
Kansas City, Missouri, 64132, United States
GSK Investigational Site
Henderson, Nevada, 89015, United States
GSK Investigational Site
Las Vegas, Nevada, 79102, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
East Orange, New Jersey, 07017, United States
GSK Investigational Site
Englewood, New Jersey, 07631, United States
GSK Investigational Site
Galloway, New Jersey, 08205, United States
GSK Investigational Site
Hoboken, New Jersey, 07030, United States
GSK Investigational Site
Jersey City, New Jersey, 07304, United States
GSK Investigational Site
Jersey City, New Jersey, 07306, United States
GSK Investigational Site
Newark, New Jersey, 07101-1709, United States
GSK Investigational Site
Newark, New Jersey, 07102, United States
GSK Investigational Site
Newark, New Jersey, 07112, United States
GSK Investigational Site
Somers Point, New Jersey, 08244, United States
GSK Investigational Site
Westfield, New Jersey, 07090, United States
GSK Investigational Site
Santa Fe, New Mexico, 87505, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Brooklyn, New York, 11201, United States
GSK Investigational Site
Brooklyn, New York, 11212, United States
GSK Investigational Site
Brooklyn, New York, 11215, United States
GSK Investigational Site
Brooklyn, New York, 11220, United States
GSK Investigational Site
Brooklyn, New York, 11237, United States
GSK Investigational Site
Great Neck, New York, 10020, United States
GSK Investigational Site
Manhasset, New York, 11030, United States
GSK Investigational Site
New York, New York, 10003, United States
GSK Investigational Site
New York, New York, 10010, United States
GSK Investigational Site
New York, New York, 10011, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10019, United States
GSK Investigational Site
New York, New York, 10022, United States
GSK Investigational Site
New York, New York, 10025, United States
GSK Investigational Site
Staten Island, New York, 10304, United States
GSK Investigational Site
The Bronx, New York, 10457, United States
GSK Investigational Site
Charlotte, North Carolina, 28211, United States
GSK Investigational Site
Huntersville, North Carolina, 28078, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cleveland, Ohio, 44109, United States
GSK Investigational Site
Portland, Oregon, 97209, United States
GSK Investigational Site
Danville, Pennsylvania, 17822, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19103, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19121, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19131, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19143, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19146, United States
GSK Investigational Site
Reading, Pennsylvania, 19601, United States
GSK Investigational Site
Greenville, South Carolina, 29605, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Johnson City, Tennessee, 37614, United States
GSK Investigational Site
Memphis, Tennessee, 38104, United States
GSK Investigational Site
Memphis, Tennessee, 38120, United States
GSK Investigational Site
Arlington, Texas, 76015, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Dallas, Texas, 75219, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
El Paso, Texas, 79905, United States
GSK Investigational Site
Galveston, Texas, 77555-0188, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77009, United States
GSK Investigational Site
Houston, Texas, 77027, United States
GSK Investigational Site
Houston, Texas, 77098, United States
GSK Investigational Site
Longview, Texas, 75604, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Tyler, Texas, 75708, United States
GSK Investigational Site
Salt Lake City, Utah, 84132, United States
GSK Investigational Site
Annandale, Virginia, 22003, United States
GSK Investigational Site
Fairfax, Virginia, 22030, United States
GSK Investigational Site
Richmond, Virginia, 23224, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, PharmD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2004
First Posted
October 18, 2004
Study Start
July 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
September 30, 2010
Record last verified: 2010-09