HIVPhase 4BIDI-MONONCT01189695
Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure
A Phase 4 study testing Ritonavir-boosted lopinavir and optimized background regimens (OBRs) in people with HIV and AIDS, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Ritonavir-boosted lopinavir and optimized background regimens (OBRs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2010to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, 11000
About this study
Official title: 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.
- Conditions
- HIV, AIDS, Lopinavir, Treatment Failure
- Being tested
- Ritonavir-boosted lopinavir, optimized background regimens (OBRs)
- Keywords
- HIV or AIDS, Lopinavir, Ritonavir, Anti-Retroviral Agents, treatment failure, treatment experienced, NNRTI failure, monotherapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritonavir-boosted lopinavirDrug
Lopinavir/ritonavir 200/50 mg every 12 hours
optimized background regimens (OBRs)Drug
Optimized background regimens such as NRTIs, etravirine or raltegravir
| Study group | Role | What they receive |
|---|---|---|
| Boosted lopinavir monotherapy | Experimental | Not described Receives: Drug: Ritonavir-boosted lopinavir |
| boosted lopinavir + optimized background regimens (OBRs) | Active comparator | Not described Receives: Drug: Ritonavir-boosted lopinavir; Drug: optimized background regimens (OBRs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (5)
Proportion of patients with virological suppression
virological suppression defined as having HIV-1 RNA <40 copies/ml
Measured: 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
Measured: 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)
Measured: 48 weeks
Change of CD4 cells count
Change of CD4 cells count from start of study to Week 48
Measured: 48 weeks
Adverse events
any grade 3 or grade 4 adverse events according to DAIDS AE grading table
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bamrasnaradura Infectious Diseases Institute
- Sponsor type
- Other government
- Collaborators
- Department of Disease Control, Thailand
- Responsible party
- Principal investigator, Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute
- Investigators
- Krittaecho Siripassorn, MD, Principal investigator, Bamrasnaradura Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189695
- Sponsor's protocol ID
- BIDI-MONO
- Acronym
- BIDI-MONO
- Status last verified
- May 2013
- First submitted
- 26 Aug 2010
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01189695
- Acronym / sponsor ID
- BIDI-MONO / BIDI-MONO
- Conditions
- HIV, AIDS, Lopinavir, Treatment Failure
- Keywords
- HIV or AIDS, Lopinavir, Ritonavir, Anti-Retroviral Agents, treatment failure, treatment experienced, NNRTI failure, monotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bamrasnaradura Infectious Diseases InstituteOther government
- Collaborators
- Department of Disease Control, Thailand
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boosted lopinavir monotherapy | Experimental | Drug: Ritonavir-boosted lopinavir |
| boosted lopinavir + optimized background regimens (OBRs) | Active comparator | Drug: Ritonavir-boosted lopinavir, Drug: optimized background regimens (OBRs) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritonavir-boosted lopinavirLopinavir/ritonavir 200/50 mg every 12 hours | Drug | Boosted lopinavir monotherapy, boosted lopinavir + optimized background regimens (OBRs) |
| optimized background regimens (OBRs)Optimized background regimens such as NRTIs, etravirine or raltegravir | Drug | boosted lopinavir + optimized background regimens (OBRs) |
Primary outcome
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
5 secondary outcomes
Proportion of patients with virological suppression
Time frame: 48 weeks
Proportion of patients with virological failure
Time frame: 48 week
Time to loss of virological response (TLOVR)
Time frame: 48 weeks
Change of CD4 cells count
Time frame: 48 weeks
Adverse events
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krittaecho Siripassorn, MD principal investigator
Bamrasnaradura Infectious Diseases Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ritonavir-boosted lopinavir and optimized background regimens (OBRs) in people with HIV and AIDS, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to virological failure (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.