HIV-1 InfectionSIMPLENCT02581202
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
An observational study of HIV-1 Infection, run by AbbVie.
Trial summary
This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- lopinavir/ritonavir and lamivudine
- Type of treatment
- Pill or oral medicine
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2015to 27 May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-1 infected participants on any triple HAART with undetectable plasma HIV-1 RNA level for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC in the routine clinical settings.
Who may be able to join
- Age 18 years and older (male and female).
- HIV-1 infected patients on any triple HAART with plasma HIV-1 RNA level <50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r + 3TC) no more than 60 days ago.
- Cumulative HAART experience at least 6 months.
- Authorization (Consent) for Use/Disclosure of Data signed by the patient.
Who cannot join
- Contraindications to lopinavir/ritonavir and lamivudine
- Previous participation in this program
About this study
Official title: ProSpective, MultI-Center, Observational PrograM to Assess the Effectiveness of Dual TheraPy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Routine Clinical Settings of the Russian Federation (SIMPLE)
This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.
- Conditions
- HIV-1 Infection
- Being tested
- lopinavir/ritonavir, lamivudine
- Keywords
- antiretroviral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavir/ritonavirDrug
tablet
lamivudineDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 infected participants | HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment. Receives: Drug: lopinavir/ritonavir; Drug: lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48
Measured: Week 48
Secondary outcomes (35)
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24
Measured: Week 24
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
Measured: Baseline, Week 24
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL).
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
Measured: Baseline, Week 48
Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
Measured: Week 48
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol
Measured: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides
Measured: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides
Measured: Baseline, Week 48
Number of Participants With Adverse Events
Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation.
Measured: up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start21 Dec 2015
- Primary completion27 May 2017
- Study completion27 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrey Strugovschikov, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581202
- Sponsor's protocol ID
- P15-452
- Acronym
- SIMPLE
- Status last verified
- May 2018
- First submitted
- 19 Oct 2015
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProSpective, MultI-Center, Observational PrograM to Assess the Effectiveness of Dual TheraPy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Routine Clinical Settings of the Russian Federation (SIMPLE)
- ClinicalTrials.gov ID
- NCT02581202
- Acronym / sponsor ID
- SIMPLE / P15-452
- Conditions
- HIV-1 Infection
- Keywords
- antiretroviral therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2015
- Primary completion
- 27 May 2017 (actual)
- Study completion
- 27 May 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Posted 29 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 infected participants | – | Drug: lopinavir/ritonavir, Drug: lamivudineHIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected participants on any triple HAART with undetectable plasma HIV-1 RNA level for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC in the routine clinical settings.
Key inclusion criteria (4 listed)
- Age 18 years and older (male and female).
- HIV-1 infected patients on any triple HAART with plasma HIV-1 RNA level <50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r + 3TC) no more than 60 days ago.
- Cumulative HAART experience at least 6 months.
- Authorization (Consent) for Use/Disclosure of Data signed by the patient.
Key exclusion criteria (2 listed)
- Contraindications to lopinavir/ritonavir and lamivudine
- Previous participation in this program
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/ritonavirtablet | Drug | HIV-1 infected participants |
| lamivudinetablet | Drug | HIV-1 infected participants |
Primary outcome
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48
Time frame: Week 48
35 secondary outcomes
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24
Time frame: Week 24
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
Time frame: Baseline, Week 48
Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
Time frame: Week 48
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol
Time frame: Baseline, Week 48
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides
Time frame: Baseline, Week 24
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides
Time frame: Baseline, Week 48
Number of Participants With Adverse Events
Time frame: up to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for HIV-1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
Andrey Strugovschikov, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 Infection, run by AbbVie.
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 4 inclusion and 2 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 (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 Jun 2019.