Status:
COMPLETED
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)
Lead Sponsor:
GlaxoSmithKline
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00094367
Start Date
July 1 2004
End Date
October 1 2005
Last Update
September 30 2010
Active Locations (178)
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1
GSK Investigational Site
Montgomery, Alabama, United States, 36105
2
GSK Investigational Site
Glendale, Arizona, United States, 85306
3
GSK Investigational Site
Phoenix, Arizona, United States, 85006
4
GSK Investigational Site
Phoenix, Arizona, United States, 85015