HIV InfectionsPhase 4NCT00405171
Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia
A Phase 4 study testing Nevirapine in people with HIV Infections and Hypercholesterolemia, run by University Hospital, Caen at 1 site in France.
Trial summary
Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Hypercholesterolemia, Antiretroviral Therapy
- What is being tested?
- Nevirapine
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2003to Feb 2006
- 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
- HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
- plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
- Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD
- Low-Density Lipoprotein cholesterol (LDL-c)>4.1 mmol/L regardless of CHD risk factors.
Who cannot join
- Protease inhibitors use within the previous 6 months,
- Prior exposure to nevirapine
- Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
- AST or ALT>1.25N if hepatitis virus B or C were positive
- Fasting glycemia>1.26g/L,
- Current CHD
- Triglycerides>4.6 mmol/L
- Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.
- Conditions
- HIV Infections, Hypercholesterolemia, Antiretroviral Therapy
- Being tested
- Nevirapine
- Keywords
- Efavirenz, Nevirapine, Dyslipidemia, HIV
- Medical subject headings
- HIV Infections, Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in LDL cholesterol between baseline and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startJun 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Investigators
- Jean-Jacques Parienti, MD, Principal investigator, University Hospital, CaenRenaud Verdon, MD, PhD, Study chair, Côte de Nacre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405171
- Sponsor's protocol ID
- SIROCCO
- Status last verified
- Oct 2010
- First submitted
- 27 Nov 2006
- Last updated
- 28 Oct 2010
- Results posted
- No
Publications
Parienti JJ, Peytavin G, Reliquet V, Verdon R, Coquerel A. Pharmacokinetics of the treatment switch from efavirenz to nevirapine. Clin Infect Dis. 2010 Jun 1;50(11):1547-8. doi: 10.1086/652718. No abstract available.
PubMed 20433360Parienti JJ, Massari V, Rey D, Poubeau P, Verdon R; SIROCCO study team. Efavirenz to nevirapine switch in HIV-1-infected patients with dyslipidemia: a randomized, controlled study. Clin Infect Dis. 2007 Jul 15;45(2):263-6. doi: 10.1086/518973. Epub 2007 Jun 6.
PubMed 17578790
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00405171
- Acronym / sponsor ID
- SIROCCO
- Conditions
- HIV Infections, Hypercholesterolemia, Antiretroviral Therapy
- Keywords
- Efavirenz, Nevirapine, Dyslipidemia, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jun 2003
- Study completion
- Feb 2006
- First posted
- 29 Nov 2006 (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.
Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
- plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
- Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD
- Low-Density Lipoprotein cholesterol (LDL-c)>4.1 mmol/L regardless of CHD risk factors.
Key exclusion criteria (8 listed)
- Protease inhibitors use within the previous 6 months,
- Prior exposure to nevirapine
- Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
- AST or ALT>1.25N if hepatitis virus B or C were positive
- Fasting glycemia>1.26g/L,
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 |
|---|---|---|
| Nevirapine | Drug | – |
Primary outcome
Decrease in LDL cholesterol between baseline and week 52
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 28 Oct 2010.
- Background: PubMed 20433360Parienti JJ, Peytavin G, Reliquet V, Verdon R, Coquerel A. Pharmacokinetics of the treatment switch from efavirenz to nevirapine. Clin Infect Dis. 2010 Jun 1;50(11):1547-8. doi: 10.1086/652718. No abstract available.
- Results publication: PubMed 17578790Parienti JJ, Massari V, Rey D, Poubeau P, Verdon R; SIROCCO study team. Efavirenz to nevirapine switch in HIV-1-infected patients with dyslipidemia: a randomized, controlled study. Clin Infect Dis. 2007 Jul 15;45(2):263-6. doi: 10.1086/518973. Epub 2007 Jun 6.
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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.
Jean-Jacques Parienti, MD principal investigator
University Hospital, Caen
Renaud Verdon, MD, PhD study chair
Côte de Nacre
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 Nevirapine in people with HIV Infections and Hypercholesterolemia, run by University Hospital, Caen 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 4 inclusion and 8 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 28 Oct 2010. 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.
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?
Decrease in LDL cholesterol between baseline and week 52. 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 NCT00405171, which also lists 2 linked publications.
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 28 Oct 2010.