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 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||See Detailed Description|
- 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.
|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.
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|Study Director:||GSK Clinical Trials, PharmD||GlaxoSmithKline|