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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV, AIDS, Lopinavir, Treatment Failure

Intervention / Treatment
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* Drug: Ritonavir-boosted lopinavir
* Drug: optimized background regimens (OBRs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boosted lopinavir monotherapy<br> | Drug: Ritonavir-boosted lopinavir<br>* Lopinavir/ritonavir 200/50 mg every 12 hours<br>|
| Active Comparator: boosted lopinavir + optimized background regimens (OBRs)<br> | Drug: Ritonavir-boosted lopinavir<br>* Lopinavir/ritonavir 200/50 mg every 12 hours<br>Drug: optimized background regimens (OBRs)<br>* Optimized background regimens such as NRTIs, etravirine or raltegravir<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with virological suppression | virological suppression defined as having HIV-1 RNA <40 copies/ml | 48 weeks | 
| Proportion of patients with virological failure | virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks | 48 week | 
| Time to loss of virological response (TLOVR) | 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) | 48 weeks | 
| Change of CD4 cells count | Change of CD4 cells count from start of study to Week 48 | 48 weeks | 
| Adverse events | any grade 3 or grade 4 adverse events according to DAIDS AE grading table | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV or AIDS, Lopinavir, Ritonavir, Anti-Retroviral Agents, treatment failure, treatment experienced, NNRTI failure, monotherapy