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

NCT ID: NCT01189695

Last Updated: 2013-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-01-31

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.

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Detailed Description

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Conditions

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HIV AIDS Lopinavir Treatment Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Boosted lopinavir monotherapy

Group Type EXPERIMENTAL

Ritonavir-boosted lopinavir

Intervention Type DRUG

Lopinavir/ritonavir 200/50 mg every 12 hours

boosted lopinavir + optimized background regimens (OBRs)

Group Type ACTIVE_COMPARATOR

Ritonavir-boosted lopinavir

Intervention Type DRUG

Lopinavir/ritonavir 200/50 mg every 12 hours

optimized background regimens (OBRs)

Intervention Type DRUG

Optimized background regimens such as NRTIs, etravirine or raltegravir

Interventions

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Ritonavir-boosted lopinavir

Lopinavir/ritonavir 200/50 mg every 12 hours

Intervention Type DRUG

optimized background regimens (OBRs)

Optimized background regimens such as NRTIs, etravirine or raltegravir

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Disease Control, Thailand

UNKNOWN

Sponsor Role collaborator

Bamrasnaradura Infectious Diseases Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Krittaecho Siripassorn

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krittaecho Siripassorn, MD

Role: PRINCIPAL_INVESTIGATOR

Bamrasnaradura Infectious Diseases Institute

Locations

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Bamrasnaradura Infectious Diseases Institute

Nonthaburi, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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BIDI-MONO

Identifier Type: -

Identifier Source: org_study_id

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