Human Immunodeficiency Virus 1Phase 2MONARCHNCT01391013
A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients
A Phase 2 study testing Darunavir(DRV), Ritonavir and 2 nucleoside reverse transcriptase inhibitors (NRTIs) in people with Human Immunodeficiency Virus 1, run by Janssen-Cilag S.p.A..
Trial summary
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus 1
- What is being tested?
- Darunavir(DRV), Ritonavir and 2 nucleoside reverse transcriptase inhibitors (NRTIs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Apr 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of coronary heart disease, uncontrolled hypertension, peripheral vascular disease and or cerebrovascular disease
- History of virological failure on highly active antiretroviral therapy, plasma HIV-1 ribonucleic acid more than 500 copies/mL after initial full virological suppression while on ARV therapy and any PI mutations
- Participants with significantly hepatic and liver insufficiency or diagnosed with acute viral hepatitis or have active clinically significant diseases and acquired immune deficiency syndrome (AIDS) defining illness at screening
- Current significant tobacco use, active drug or alcohol use or dependence
- Use of lipid-lowering drugs within 4 weeks prior to study entry and use of testosterone, anabolic steroids, oral contraceptives or hormonal replacement within 12 weeks prior to study entry or previous or current use of darunavir
- Use of systemic glucocorticoids, long-acting inhaled steroids (inhaled via mouth or nose), or other immunomodulators within 30 days prior to study entry
About this study
Official title: A Randomised, Controlled, Open-Label Trial to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg O.D. Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Subjects With Undetectable Plasma HIV-1 RNA on Their Current Treatments.
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected participants.
Read the detailed description
This is a Phase II, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), controlled, single centre study. The study consists of 3 phases including, the screening phase (4 weeks before administration of study medication), treatment phase (48 weeks), and the follow-up phase (4 weeks). In the treatment phase, HIV-infected participants who have not changed their first-line treatment of highly active antiretroviral therapy (HAART) for at least 8 weeks and have documented evidence of their HIV- ribonucleic acid (RNA) measurements being virologically suppressed (HIV-RNA less than 50 copies/mL) for at least 24 weeks prior to the screening, will be randomly assigned equally in two treatment arms: triple combination therapy arm (DRV/r 800/100 mg once daily plus 2 NRTIs) or monotherapy arm (DRV/r 800/100 mg once daily). Participants in the triple combination arm who are already on 2 NRTIs prior to randomization may remain on these or switch them at baseline, where the participants on the monotherapy arm will discontinue HAART at baseline and will start DRV/r 800/100 mg once daily. Safety evaluations will include assessment of adverse events, significant vital signs, and significant laboratory tests. The total duration of the study will be 56 weeks.
- Conditions
- Human Immunodeficiency Virus 1
- Being tested
- Darunavir(DRV), Ritonavir, 2 nucleoside reverse transcriptase inhibitors (NRTIs)
- Keywords
- Human immunodeficiency virus 1, Acquired immunodeficiency syndrome, Immunologic deficiency syndrome, Darunavir/ritonavir, Darunavir, Ritonavir, Nucleoside reverse transcriptase inhibitors (NRTIs), Prezista
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir(DRV)Drug
Also called Prezista
Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks
RitonavirDrug
Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks
2 nucleoside reverse transcriptase inhibitors (NRTIs)Drug
2 NRTIs will be administered as per the package inserts.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | Monotherapy: darunavir/ritonavir (DRV/r) will be administered for 48 weeks. Receives: Drug: Darunavir(DRV); Drug: Ritonavir |
| Combination therapy | Experimental | DRV/r along with 2 nucleoside reverse transcriptase inhibitors (NRTIs) will be administered for 48 weeks and whenever possible, participants should take these medications at the same time. Switch of NRTIs will be allowed in the event of suspected toxicity/intolerance, providing this change can be linked to a documented adverse event (AE)/serious AE. Receives: Drug: Darunavir(DRV); Drug: Ritonavir; Drug: 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.
Measured: Baseline (Day 1 of Week 1) to Week 24
Secondary outcomes (16)
Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.
Measured: Baseline to Week 48
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Measured: Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)
Change From Baseline to Week 48 in Circulating Endothelial Cells
Measured: Baseline to Week 48
Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells
Measured: Baseline to Week 48
Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL
Measured: Baseline (Day1 of Week 1), Week 24, and Week 48
Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL
Measured: Baseline, Week 24, and Week 48
Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides
Measured: Baseline, Week 24, and Week 48
Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
The Homeostatic Model Assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. HOMA-IR is reflected in the diminished effect of insulin on hepatic glucose production. HOMA-IR is calculated as: (Glucose [mg/dL] X Insulin [pmol/L]) / (405 X 6.945). Higher scores indicate worse insulin resistance.
Measured: Baseline, Week 24, and Week 48
Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score
The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of a participant. It is calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, and systolic blood pressure. The framingham risk score is calculated as: for males: 0 point (1 percentage) up to 17 points (30 percentages); whereas for females: 0 to 9 points (1 percentage) up to 25 points (30 percentage). Higher scores indicate high cardiovascular risk.
Measured: Baseline, Week 24, and Week 48
Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)
Leg fat content will be analyzed by Dual Energy X-ray Absortiometry (DEXA scan).
Measured: Baseline to Week 48
Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)
Visceral fat content in abdomen will be analyzed with median change in VAT by an abdomen Computerized Tomography.
Measured: Baseline to Week 48
Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score
T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.
Measured: Baseline to Week 48
Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score
Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density.
Measured: Baseline to Week 48
Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score
T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.
Measured: Baseline to Week 48
Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score
Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density.
Measured: Baseline to Week 48
Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48
Measured: Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionApr 2011
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 Human Immunodeficiency Virus 1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.p.A. Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391013
- Sponsor's protocol ID
- CR017575
- Other IDs
- TMC114HIV3017, TMC-C-07-IT-016
- Acronym
- MONARCH
- Status last verified
- May 2013
- First submitted
- 23 Jun 2011
- Last updated
- 27 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Open-Label Trial to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg O.D. Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Subjects With Undetectable Plasma HIV-1 RNA on Their Current Treatments.
- ClinicalTrials.gov ID
- NCT01391013
- Acronym / sponsor ID
- MONARCH / CR017575
- Conditions
- Human Immunodeficiency Virus 1
- Keywords
- Human immunodeficiency virus 1, Acquired immunodeficiency syndrome, Immunologic deficiency syndrome, Darunavir/ritonavir, Darunavir, Ritonavir, Nucleoside reverse transcriptase inhibitors (NRTIs), Prezista
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 27 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected participants.
Detailed description
This is a Phase II, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), controlled, single centre study. The study consists of 3 phases including, the screening phase (4 weeks before administration of study medication), treatment phase (48 weeks), and the follow-up phase (4 weeks). In the treatment phase, HIV-infected participants who have not changed their first-line treatment of highly active antiretroviral therapy (HAART) for at least 8 weeks and have documented evidence of their HIV- ribonucleic acid (RNA) measurements being virologically suppressed (HIV-RNA less than 50 copies/mL) for at least 24 weeks prior to the screening, will be randomly assigned equally in two treatment arms: triple combination therapy arm (DRV/r 800/100 mg once daily plus 2 NRTIs) or monotherapy arm (DRV/r 800/100 mg once daily). Participants in the triple combination arm who are already on 2 NRTIs prior to randomization may remain on these or switch them at baseline, where the participants on the monotherapy arm will discontinue HAART at baseline and will start DRV/r 800/100 mg once daily. Safety evaluations will include assessment of adverse events, significant vital signs, and significant laboratory tests. The total duration of the study will be 56 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: Darunavir(DRV), Drug: RitonavirMonotherapy: darunavir/ritonavir (DRV/r) will be administered for 48 weeks. |
| Combination therapy | Experimental | Drug: Darunavir(DRV), Drug: Ritonavir, Drug: 2 nucleoside reverse transcriptase inhibitors (NRTIs)DRV/r along with 2 nucleoside reverse transcriptase inhibitors (NRTIs) will be administered for 48 weeks and whenever possible, participants should take these medications at the same time. Switch of NRTIs will be allowed in the event of suspected toxicity/intolerance, providing this change can be linked to a documented adverse event (AE)/serious AE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- History of coronary heart disease, uncontrolled hypertension, peripheral vascular disease and or cerebrovascular disease
- History of virological failure on highly active antiretroviral therapy, plasma HIV-1 ribonucleic acid more than 500 copies/mL after initial full virological suppression while on ARV therapy and any PI mutations
- Participants with significantly hepatic and liver insufficiency or diagnosed with acute viral hepatitis or have active clinically significant diseases and acquired immune deficiency syndrome (AIDS) defining illness at screening
- Current significant tobacco use, active drug or alcohol use or dependence
- Use of lipid-lowering drugs within 4 weeks prior to study entry and use of testosterone, anabolic steroids, oral contraceptives or hormonal replacement within 12 weeks prior to study entry or previous or current use of darunavir
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 |
|---|---|---|
| Darunavir(DRV)Also: PrezistaOral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks | Drug | Combination therapy, Monotherapy |
| RitonavirOral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks | Drug | Combination therapy, Monotherapy |
| 2 nucleoside reverse transcriptase inhibitors (NRTIs)2 NRTIs will be administered as per the package inserts. | Drug | Combination therapy |
Primary outcome
Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)
Time frame: Baseline (Day 1 of Week 1) to Week 24
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.
16 secondary outcomes
Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)
Time frame: Baseline to Week 48
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Time frame: Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)
Change From Baseline to Week 48 in Circulating Endothelial Cells
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells
Time frame: Baseline to Week 48
Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL
Time frame: Baseline (Day1 of Week 1), Week 24, and Week 48
Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL
Time frame: Baseline, Week 24, and Week 48
Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides
Time frame: Baseline, Week 24, and Week 48
Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, Week 24, and Week 48
Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score
Time frame: Baseline, Week 24, and Week 48
Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score
Time frame: Baseline to Week 48
Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48
Time frame: Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janssen-Cilag S.p.A. Clinical Trial study director
Janssen-Cilag S.p.A.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darunavir(DRV), Ritonavir and 2 nucleoside reverse transcriptase inhibitors (NRTIs) in people with Human Immunodeficiency Virus 1, run by Janssen-Cilag S.p.A..
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 0 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 27 Jun 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2013). 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?
Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%) (time frame: Baseline (Day 1 of Week 1) to Week 24). 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 27 Jun 2013.