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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:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00094367
First received: October 16, 2004
Last updated: September 29, 2010
Last verified: September 2010
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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 Intervention Model: Parallel Assignment Masking: None (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) |
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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 August 23, 2017