Kozal MJ. HIV Clin Trials. 2012 May-Jun;13(3):119-30
Type of ARV Trial
Head-to-head comparative trials for first line ART since 2006
» 2 drugs vs 3 drugs
» NRTI-Sparing
» ATV + RAL vs ATV/r + FTC/TDF
Head-to-head comparative trials for first line ART since 2006
» 2 drugs vs 3 drugs
» NRTI-Sparing
» ATV + RAL vs ATV/r + FTC/TDF
Drugs
RAL, ATV/r, ATV, FTC/TDF, TDF, FTC
RAL, ATV/r, ATV, FTC/TDF, TDF, FTC
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- ATV + RAL BID achieved virologic response rate comparable to current standard of care for treatment-naïve subjects
- ATV + RAL was associated with
- Emergence of resistance to RAL in case of virologic failure
- Higher rates of severe hyperbilirubinemia compared with ATV/r 300/100 mg QD
- Could be related to higher ATV exposure
- No new or unexpected safety signals
- Study was early terminated and regimen of ATV 300 mg BID + RAL 400 mg BID considered not to be optimal for further clinical development
Design :
*Randomisation was stratified by HIV RNA (< or ≥ 100,000 c/mL)
Efficacy endpoint :
- Primary : HIV RNA < 50 copies/mL at week 24 by mITT (confirmed virologic response (CVR) with non completers counted as failure)
- Other assessments : CVR with non completers counted as missing, virologic response-observed
Baseline characteristics and patient disposition :
Response rate at week 24 :
Resistance data :
* N = 1 with Q148R, N = 1 with Q148Q/R + T97T/A, 2 with N155H
Adverse events through week 24 :
