HIVPhase 4NCT01581853
Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily
A Phase 4 study testing Lopinavir/ritonavir 800 mg / 200mg in people with HIV, run by Daniel Podzamczer at 2 sites in Spain.
Trial summary
Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Lopinavir/ritonavir 800 mg / 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesSpain
- Study dates
- May 2012to Jul 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18, HIV positive
- Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months
- Undetectable viral load (<40 copies/ml) during the last 6 months
- Patients that accept participation in the study and sign the Informed Consent Form
- Childbearing females with negative pregnancy tests and using appropriate contraceptive measures
Who cannot join
- Opportunistic disease, cancer or any other active disease with specific treatment
- Active addiction to illegal drugs or active use of psychotropic drugs
- Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved > 3 months)
- Females who are breastfeeding or pregnant
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital del Mar
Bercelona, Barcelona, 08003
Hospital Universitary de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.
- Conditions
- HIV
- Being tested
- Lopinavir/ritonavir 800 mg / 200mg
- Keywords
- HIV, AIDS, MONOTHERAPY, PILOT, LOPINAVIR/RITONAVIR
- 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.
Lopinavir/ritonavir 800 mg / 200mgDrug
Also called Kaletra 200/50 mg comprimidos recubiertos con película
Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months
| Study group | Role | What they receive |
|---|---|---|
| Lopinavir/ritonavir 800 mg / 200mg | Other | Kaletra 200/50 mg comprimidos recubiertos con película Lopinavir/ritonavir 800 mg / 200mg will be changed from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months Receives: Drug: Lopinavir/ritonavir 800 mg / 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma viral load <40 copies/mL
HIV Plasma Viral Load <40 copies/ml at week 48.
Measured: Week 48
Secondary outcomes (5)
Stability in the plasma levels of Lopinavir/ritonavir during all study visits
Determination of plasma concentrations of the study drug at weeks 4, 8, 12, 16, 24, 36 and 48
Measured: Weeks 4, 8, 12, 16, 24, 36 and 48
Tolerability
Possible Adverse Events will be collected in all study visits and laboratory tests will also be performed in all study visits (weeks 4, 8, 12, 16, 24, 36 and 48)
Measured: Weeks 4, 8, 12, 16, 24, 36 and 48
Adherence
Medication adherence will be evaluated in all the study visits after making a reconciliation of the medication dispensed and returned by the patients
Measured: Weeks 4, 8, 12, 16, 24, 36 and 48
Satisfaction
Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ)
Measured: Weeks 4, 8, 12, 16, 24, 36 and 48
- Efficacy in CSF
- In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment)
Measured: At least 4 weeks on study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2014
- Study completionJul 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Podzamczer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Podzamczer, Hospital Universitari de Bellvitge
- Investigators
- Daniel Podzamczer, MD, Principal investigator, Hospital Universitari de BellvitgeHernando Knobel, MD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581853
- Sponsor's protocol ID
- KMON
- Other IDs
- 2011-005981-39
- Status last verified
- Apr 2013
- First submitted
- 17 Apr 2012
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily
- ClinicalTrials.gov ID
- NCT01581853
- Acronym / sponsor ID
- KMON
- Conditions
- HIV
- Keywords
- HIV, AIDS, MONOTHERAPY, PILOT, LOPINAVIR/RITONAVIR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Daniel PodzamczerUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Apr 2012 (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.
Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lopinavir/ritonavir 800 mg / 200mg | Other | Drug: Lopinavir/ritonavir 800 mg / 200mgKaletra 200/50 mg comprimidos recubiertos con película Lopinavir/ritonavir 800 mg / 200mg will be changed from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18, HIV positive
- Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months
- Undetectable viral load (<40 copies/ml) during the last 6 months
- Patients that accept participation in the study and sign the Informed Consent Form
- Childbearing females with negative pregnancy tests and using appropriate contraceptive measures
Key exclusion criteria (4 listed)
- Opportunistic disease, cancer or any other active disease with specific treatment
- Active addiction to illegal drugs or active use of psychotropic drugs
- Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved > 3 months)
- Females who are breastfeeding or pregnant
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 |
|---|---|---|
| Lopinavir/ritonavir 800 mg / 200mgAlso: Kaletra 200/50 mg comprimidos recubiertos con películaLopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months | Drug | Lopinavir/ritonavir 800 mg / 200mg |
Primary outcome
plasma viral load <40 copies/mL
Time frame: Week 48
HIV Plasma Viral Load <40 copies/ml at week 48.
5 secondary outcomes
Stability in the plasma levels of Lopinavir/ritonavir during all study visits
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
Tolerability
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
Adherence
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
Satisfaction
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
- Efficacy in CSF
Time frame: At least 4 weeks on study treatment
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 6 Oct 2016.
Related trials for HIV
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
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.
Daniel Podzamczer, MD principal investigator
Hospital Universitari de Bellvitge
Hernando Knobel, MD principal investigator
Hospital del Mar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lopinavir/ritonavir 800 mg / 200mg in people with HIV, run by Daniel Podzamczer at 2 sites in Spain.
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 5 inclusion and 4 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 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
plasma viral load <40 copies/mL (time frame: Week 48). 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 6 Oct 2016.