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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01189695

Acronym

BIDI-MONO

Enrollment

Registered

2010-08-27

Start date

2010-12-31

Completion date

2013-01-31

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, AIDS, Lopinavir, Treatment Failure

Keywords

HIV or AIDS, Lopinavir, Ritonavir, Anti-Retroviral Agents, treatment failure, treatment experienced, NNRTI failure, monotherapy

Brief 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.

Interventions

DRUGRitonavir-boosted lopinavir

Lopinavir/ritonavir 200/50 mg every 12 hours

DRUGoptimized background regimens (OBRs)

Optimized background regimens such as NRTIs, etravirine or raltegravir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Time to virological failure	48 weeks	virological failure was defined as having two consecutive results of HIV-1 RNA \>400 copies/ml in time separated by 4 weeks

Secondary

Measure	Time frame	Description
Proportion of patients with virological suppression	48 weeks	virological suppression defined as having HIV-1 RNA \<40 copies/ml
Proportion of patients with virological failure	48 week	virological failure was defined as having two consecutive results of HIV-1 RNA \>400 copies/ml in time separated by 4 weeks
Time to loss of virological response (TLOVR)	48 weeks	TLOVR was defined as time between randomization and the last value that HIV-1 RNA \<40 copies/ml in a patient who initially suppressed HIV-1 RNA but subsequently demonstrated virologic rebound (two consecutive HIV-1 RNA \>40 copies/ml)
Change of CD4 cells count	48 weeks	Change of CD4 cells count from start of study to Week 48
Adverse events	48 weeks	any grade 3 or grade 4 adverse events according to DAIDS AE grading table

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026