HIV SeropositivityCOPANANCT03139630
COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients
An observational study of HIV Seropositivity and Dyslipidemias, run by Franck Boccara at 1 site in France.
Trial summary
Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity, Dyslipidemias, PCSK9
- How many people
- 193 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Sep 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-infected patients: adult male or female patients who are HIV treatment naive and initiate antiretroviral therapy including a protease inhibitor during the follow up period. HIV-uninfected patients: adult adult male or female patients.
Who may be able to join
- Naive HIV-infected male or female > 18 years
- Initiation of antiretroviral therapy including a protestase inhibitor during the follow up with blood samples available
- Patients controlled at one year with a VL<400 copies/ml
Who cannot join
- Subjects under statin or other lipid lowering drugs (fenofibrate, ezetimibe)
Trial locations and contacts
1 site in 1 country.
France1 site
Cardiology Department, Saint Antoine University Hospital
Paris, 75012
About this study
Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.
Read the detailed description
Background: HIV-infected subjects are at high risk of coronary heart disease (CHD) partly in relation with atherogenic dyslipidemia including increased triglycerides (TG) and LDL-cholesterol (LDL-C). Mechanisms of HIV-associated dyslipidemia are complex, involving HIV itself and some antiretrovirals (ARV), particularly protease inhibitors (PI/r). Elevated proprotein convertase subtilisin kexin 9 (PCSK9) level is associated with increased LDL-C in the general population. How PCSK9 level is regulated in HIV-infected treated patients has never been investigated.
Objectives: We aimed to identify factors associated with circulating PCSK9 concentration in ART-naïve and treated patients and to evaluate the impact of 1st line ARV therapy (ART) comprising a PI/r, on PCSK9 level in HIV-infected patients.
Methods: Fasting plasma concentrations of PCSK9 were measured using ELISA assay in HIV-infected individuals from the ANRS COPANA cohort, at ART initiation and after one year of PI/r-based therapy without any disruption. Subjects not virologically suppressed at follow-up, or taking any lipid lowering therapies at baseline or during follow-up were excluded. Spearman's correlation coefficient was used to determine the association between PCSK9 levels and metabolic parameters at baseline and under PI/r.
- Conditions
- HIV Seropositivity, Dyslipidemias, PCSK9
- Keywords
- HIV, Dyslipidemia, Dyslipidemia, Protease Inhibitor, Ritonavir, PCSK9, Observational
- Medical subject headings
- HIV Seropositivity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected patients | HIV-infected adult male or female patients who are HIV treatment naive and initiate antiretroviral therapy including a protease inhibitor during the follow up period. | |
| HIV-uninfected patients | HIV-uninfected adult male or female patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCSK9 plasma level change after initiation of ART including protease inhibitor boosted with ritonavir (PI/r)
Mean percent change in PCSK9 plasma levels after initiation of ART including protease inhibitor boosted with ritonavir (PI/r)r in naïve HIV-infected patients: comparison of values at ART initiation.
Measured: 1 year
Secondary outcomes (3)
PCSK9 correlation with lipid parameters
Correlations between PCSK9 levels under PI/r and lipid parameters (LDLc, HDLc, triglycerides) and other parameters (glycemia, HOMA_IR) - from baseline to end.
Measured: 1 year
PCSK9 correlation with inflammatory makers/adipocytokines
Comparison of inflammatory makers/adipocytokines (IL6, hsCRP, leptin, adiponectin) and PCSK9 change - from baseline (naive) to after ART initiation.
Measured: 1 year
PCSK9 comparison between HIV-infected and uninfected patients
Comparisons of PCSK9 levels between controls (HIV-uninfected from blood donors) and HIV-infected patients - from baseline (naive) and after ART initiation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franck Boccara
- Sponsor type
- University, hospital or other
- Collaborators
- National Agency for Research on AIDS and Viral Hepatitis (ANRS), Institut National de la Santé Et de la Recherche Médicale, France, Amgen
- Responsible party
- Sponsor-investigator, Franck Boccara, Saint Antoine University Hospital
- Investigators
- Franck Boccara, MD, PhD, Principal investigator, Saint Antoine University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139630
- Sponsor's protocol ID
- COPANA - A09 PCSK 9 substudy
- Acronym
- COPANA
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2016
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share IPD
Publications
Boccara F, Ghislain M, Meyer L, Goujard C, Le May C, Vigouroux C, Bastard JP, Fellahi S, Capeau J, Cohen A, Cariou B; ANRS-COPANA Study Group. Impact of protease inhibitors on circulating PCSK9 levels in HIV-infected antiretroviral-naive patients from an ongoing prospective cohort. AIDS. 2017 Nov 13;31(17):2367-2376. doi: 10.1097/QAD.0000000000001633.
PubMed 28857822
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT03139630
- Acronym / sponsor ID
- COPANA / COPANA - A09 PCSK 9 substudy
- Conditions
- HIV Seropositivity, Dyslipidemias, PCSK9
- Keywords
- HIV, Dyslipidemia, Dyslipidemia, Protease Inhibitor, Ritonavir, PCSK9, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Franck BoccaraUniversity, hospital or other
- Collaborators
- National Agency for Research on AIDS and Viral Hepatitis (ANRS), Institut National de la Santé Et de la Recherche Médicale, France, Amgen
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 May 2017 (actual)
- 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.
Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.
Detailed description
Background: HIV-infected subjects are at high risk of coronary heart disease (CHD) partly in relation with atherogenic dyslipidemia including increased triglycerides (TG) and LDL-cholesterol (LDL-C). Mechanisms of HIV-associated dyslipidemia are complex, involving HIV itself and some antiretrovirals (ARV), particularly protease inhibitors (PI/r). Elevated proprotein convertase subtilisin kexin 9 (PCSK9) level is associated with increased LDL-C in the general population. How PCSK9 level is regulated in HIV-infected treated patients has never been investigated.
Objectives: We aimed to identify factors associated with circulating PCSK9 concentration in ART-naïve and treated patients and to evaluate the impact of 1st line ARV therapy (ART) comprising a PI/r, on PCSK9 level in HIV-infected patients.
Methods: Fasting plasma concentrations of PCSK9 were measured using ELISA assay in HIV-infected individuals from the ANRS COPANA cohort, at ART initiation and after one year of PI/r-based therapy without any disruption. Subjects not virologically suppressed at follow-up, or taking any lipid lowering therapies at baseline or during follow-up were excluded. Spearman's correlation coefficient was used to determine the association between PCSK9 levels and metabolic parameters at baseline and under PI/r.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected patients | – | –HIV-infected adult male or female patients who are HIV treatment naive and initiate antiretroviral therapy including a protease inhibitor during the follow up period. |
| HIV-uninfected patients | – | –HIV-uninfected adult male or female patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients: adult male or female patients who are HIV treatment naive and initiate antiretroviral therapy including a protease inhibitor during the follow up period. HIV-uninfected patients: adult adult male or female patients.
Key inclusion criteria (3 listed)
- Naive HIV-infected male or female > 18 years
- Initiation of antiretroviral therapy including a protestase inhibitor during the follow up with blood samples available
- Patients controlled at one year with a VL<400 copies/ml
Key exclusion criteria (1 listed)
- Subjects under statin or other lipid lowering drugs (fenofibrate, ezetimibe)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PCSK9 plasma level change after initiation of ART including protease inhibitor boosted with ritonavir (PI/r)
Time frame: 1 year
Mean percent change in PCSK9 plasma levels after initiation of ART including protease inhibitor boosted with ritonavir (PI/r)r in naïve HIV-infected patients: comparison of values at ART initiation.
3 secondary outcomes
PCSK9 correlation with lipid parameters
Time frame: 1 year
PCSK9 correlation with inflammatory makers/adipocytokines
Time frame: 1 year
PCSK9 comparison between HIV-infected and uninfected patients
Time frame: 1 year
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 30 Jan 2024.
- Derived from this study: PubMed 28857822Boccara F, Ghislain M, Meyer L, Goujard C, Le May C, Vigouroux C, Bastard JP, Fellahi S, Capeau J, Cohen A, Cariou B; ANRS-COPANA Study Group. Impact of protease inhibitors on circulating PCSK9 levels in HIV-infected antiretroviral-naive patients from an ongoing prospective cohort. AIDS. 2017 Nov 13;31(17):2367-2376. doi: 10.1097/QAD.0000000000001633.
- Individual participant dataSharing planned: No. no plan to share IPD
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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.
Franck Boccara, MD, PhD principal investigator
Saint Antoine University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and Dyslipidemias, run by Franck Boccara at 1 site in France.
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 3 inclusion and 1 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 30 Jan 2024. 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 France. 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.
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?
PCSK9 plasma level change after initiation of ART including protease inhibitor boosted with ritonavir (PI/r) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03139630, which also lists 1 linked publication.
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 30 Jan 2024.