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)
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ClinicalTrials.gov Identifier: NCT00094367 |
Recruitment Status
:
Completed
First Posted
: October 18, 2004
Last Update Posted
: September 30, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Abacavir/Lamivudine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 900 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | See Detailed Description |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094367

Study Director: | GSK Clinical Trials, PharmD | GlaxoSmithKline |
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00094367 History of Changes |
Other Study ID Numbers: |
101822 |
First Posted: | October 18, 2004 Key Record Dates |
Last Update Posted: | September 30, 2010 |
Last Verified: | September 2010 |
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 |