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)
Phase 3
Completed
- Conditions
- HIV Infection
- Registration Number
- NCT00094367
- Lead Sponsor
- GlaxoSmithKline
- 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 took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The occurrence of treatment-limiting adverse events after starting study drugs.
- Secondary Outcome Measures
Name Time Method 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. occurrence of abacavir HSR
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Milwaukee, Wisconsin, United States