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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bamrasnaradura Infectious Diseases Institute
• Collaborator: Department of Disease Control, Thailand
• Treatments: Lopinavir; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir

Criteria

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