- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189695
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)
May 10, 2013 updated by: Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nonthaburi, Thailand, 11000
- Bamrasnaradura Infectious Diseases Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Boosted lopinavir monotherapy
|
Lopinavir/ritonavir 200/50 mg every 12 hours
|
ACTIVE_COMPARATOR: boosted lopinavir + optimized background regimens (OBRs)
|
Lopinavir/ritonavir 200/50 mg every 12 hours
Optimized background regimens such as NRTIs, etravirine or raltegravir
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to virological failure
Time Frame: 48 weeks
|
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
Time Frame: 48 weeks
|
virological suppression defined as having HIV-1 RNA <40 copies/ml
|
48 weeks
|
Proportion of patients with virological failure
Time Frame: 48 week
|
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)
Time Frame: 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)
|
48 weeks
|
Change of CD4 cells count
Time Frame: 48 weeks
|
Change of CD4 cells count from start of study to Week 48
|
48 weeks
|
Adverse events
Time Frame: 48 weeks
|
any grade 3 or grade 4 adverse events according to DAIDS AE grading table
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
January 1, 2013
Study Registration Dates
First Submitted
August 26, 2010
First Submitted That Met QC Criteria
August 26, 2010
First Posted (ESTIMATE)
August 27, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 13, 2013
Last Update Submitted That Met QC Criteria
May 10, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Lopinavir
Other Study ID Numbers
- BIDI-MONO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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