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)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00094367
First received: October 16, 2004
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Abacavir/Lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The occurrence of treatment-limiting adverse events after starting study drugs.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 900
Study Start Date: July 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Abacavir/Lamivudine
    Other Name: Abacavir/Lamivudine
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094367

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Locations
United States, Alabama
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Montgomery, Alabama, United States, 36105
United States, Arizona
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Glendale, Arizona, United States, 85306
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Phoenix, Arizona, United States, 85006
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Phoenix, Arizona, United States, 85015
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Tucson, Arizona, United States, 85745
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Arleta, California, United States, 91331
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Beverly Hills, California, United States, 90211
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Fresno, California, United States, 93720
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New York, New York, United States, 10022
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Philadelphia, Pennsylvania, United States, 19121
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Houston, Texas, United States, 77027
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Houston, Texas, United States, 77004
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Houston, Texas, United States, 77009
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Longview, Texas, United States, 75604
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Tyler, Texas, United States, 75708
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Salt Lake City, Utah, United States, 84132
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Annandale, Virginia, United States, 22003
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Fairfax, Virginia, United States, 22030
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Richmond, Virginia, United States, 23224
United States, Washington
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Spokane, Washington, United States, 99204
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53212
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, PharmD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00094367     History of Changes
Other Study ID Numbers: 101822
Study First Received: October 16, 2004
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
1592U89
GR109714
abacavir
lamivudine
fixed-dose combination
once-daily
twice-daily
HIV infection
naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 22, 2014