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

Bamrasnaradura Infectious Diseases Institute

Status and phase

Completed

Phase 4

Conditions

Treatment Failure

AIDS

Lopinavir

HIV

Treatments

Drug: optimized background regimens (OBRs)

Drug: Ritonavir-boosted lopinavir

Study type

Interventional

Funder types

Other

Identifiers

NCT01189695

BIDI-MONO

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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