Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure

A Randomized Controlled Study Compares the 48 Weeks Results of HIV-1 RNA Between Ritonavir-boosted Lopinavir Monotherapy and Ritonavir-boosted Lopinavir + Optimized Background Regimens in HIV-1 Infected Patients Who Have HIV-1 RNA <50 Copies/ml More Than 6 Months While Receiving Salvage PI-based Regimen and Previously Failed NNRTI-based Regimen

The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.

Inclusion Criteria:

• age 18-60 years
• documented HIV infection
• previously failed to NNRTI-based regimens
• no history of failing PI-based regimens
• receiving ritonavir-boosted PI + OBRs(such as NRITs, etravirine, raltegravir)
• having HIV-1 RNA <50 copies/ml for at least prior 6 months

Exclusion Criteria:

• Pregnant or breastfeeding woman
• HBV co-infection that had to treated with TDF, FTC or 3TC
• had to received medications known to have potential significant drug interaction with LPV/r
• life expectancy less than 6 months
• serious systemic diseases such as liver cirrhosis Child-Pugh B/C, ESRD, malignancy
• hemoglobin <8 g/dl, platelet <50,000/mm3, AST or ALT >3 ULN, estimated creatinine clearance <50 mL/min