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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Abacavir Abacavir sulfate

U.S. FDA Resources

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)

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 (Adult, Senior)
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

Show 178 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, PharmD	GlaxoSmithKline

More Information


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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine	Abacavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 28, 2016

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