HIV InfectionsPhase 4LIPOTAR-07NCT00759070
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
A Phase 4 study testing Tenofovir + emtricitabine + efavirenz and Tenofovir + emtricitabine + lopinavir/ritonavir in people with HIV Infections, run by Juan A. Arnaiz at 5 sites in Spain.
Trial summary
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir + emtricitabine + efavirenz and Tenofovir + emtricitabine + lopinavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesSpain
- Study dates
- Sep 2008to Jul 2013
- 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
- Chronic HIV-1 infection
- Age 18 or above
- Antiretroviral-naive
- Criteria for antiretroviral therapy in accordance with current guidelines
- Plasma LDL-cholesterol below 190 mg/dL
- Not receiving lipid-lowering agents
- Written informed consent
Who cannot join
- Use of phytosterol-enriched food previous month.
- Pregnancy or breastfeeding
- Cardiovascular disease
- Secondary Hypercholesterolemia
- Plasma creatinine above 1,2 mg/dL)
- Aminotransferases above 5 times ULN
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- Current treatment for hepatitis C coinfection
- Diabetes mellitus (fasting glycemia > 124 mg/dL)
- Illegal drug use or alcohol abuse
- Active AIDS-defining opportunistic disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Clinic
Barcelona, Barcelona, 08036
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Hospital Joan XXIII
Tarragona, Tarragona, 43007
About this study
Official title: Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Tenofovir + emtricitabine + efavirenz, Tenofovir + emtricitabine + lopinavir/ritonavir
- Keywords
- Treatment Naïve
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir + emtricitabine + efavirenzDrug
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)
+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily
Tenofovir + emtricitabine + lopinavir/ritonavirDrug
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) Receives: Drug: Tenofovir + emtricitabine + efavirenz |
| 2 | Active comparator | Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV) Receives: Drug: Tenofovir + emtricitabine + lopinavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total cholesterol and HDL and LDL fractions
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Universitari Joan XXIII de Tarragona., Hospitales Universitarios Virgen del Rocío
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759070
- Sponsor's protocol ID
- LIPOTAR-07
- Other IDs
- EudraCT number: 2007-002698-29
- Acronym
- LIPOTAR-07
- Status last verified
- Feb 2013
- First submitted
- 23 Sep 2008
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Leyes P, Cofan M, Gonzalez-Cordon A, de Lazzari E, Trabal J, Domingo P, Negredo E, Vidal F, Forga MT, Gatell JM, Ros E, Martinez E. Increased cholesterol absorption rather than synthesis is involved in boosted protease inhibitor-associated hypercholesterolaemia. AIDS. 2018 Jun 19;32(10):1309-1316. doi: 10.1097/QAD.0000000000001837.
PubMed 29683854Egana-Gorrono L, Martinez E, Domingo P, Lonca M, Escriba T, Fontdevila J, Vidal F, Negredo E, Gatell JM, Arnedo M. Differential subcutaneous adipose tissue gene expression patterns in a randomized clinical trial of efavirenz or lopinavir-ritonavir in antiretroviral-naive patients. Antimicrob Agents Chemother. 2014 Nov;58(11):6717-23. doi: 10.1128/AAC.03481-14. Epub 2014 Aug 25.
PubMed 25155608
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
- ClinicalTrials.gov ID
- NCT00759070
- Acronym / sponsor ID
- LIPOTAR-07 / LIPOTAR-07
- Conditions
- HIV Infections
- Keywords
- Treatment Naïve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Universitari Joan XXIII de Tarragona., Hospitales Universitarios Virgen del Rocío
- Study start
- Sep 2008
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 25 Sep 2008 (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.
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tenofovir + emtricitabine + efavirenzTenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) |
| 2 | Active comparator | Drug: Tenofovir + emtricitabine + lopinavir/ritonavirTenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic HIV-1 infection
- Age 18 or above
- Antiretroviral-naive
- Criteria for antiretroviral therapy in accordance with current guidelines
- Plasma LDL-cholesterol below 190 mg/dL
Key exclusion criteria (10 listed)
- Use of phytosterol-enriched food previous month.
- Pregnancy or breastfeeding
- Cardiovascular disease
- Secondary Hypercholesterolemia
- Plasma creatinine above 1,2 mg/dL)
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 |
|---|---|---|
| Tenofovir + emtricitabine + efavirenzTenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) + Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily | Drug | 1 |
| Tenofovir + emtricitabine + lopinavir/ritonavirTenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID | Drug | 2 |
Primary outcome
Changes in total cholesterol and HDL and LDL fractions
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Derived from this study: PubMed 29683854Leyes P, Cofan M, Gonzalez-Cordon A, de Lazzari E, Trabal J, Domingo P, Negredo E, Vidal F, Forga MT, Gatell JM, Ros E, Martinez E. Increased cholesterol absorption rather than synthesis is involved in boosted protease inhibitor-associated hypercholesterolaemia. AIDS. 2018 Jun 19;32(10):1309-1316. doi: 10.1097/QAD.0000000000001837.
- Derived from this study: PubMed 25155608Egana-Gorrono L, Martinez E, Domingo P, Lonca M, Escriba T, Fontdevila J, Vidal F, Negredo E, Gatell JM, Arnedo M. Differential subcutaneous adipose tissue gene expression patterns in a randomized clinical trial of efavirenz or lopinavir-ritonavir in antiretroviral-naive patients. Antimicrob Agents Chemother. 2014 Nov;58(11):6717-23. doi: 10.1128/AAC.03481-14. Epub 2014 Aug 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 Tenofovir + emtricitabine + efavirenz and Tenofovir + emtricitabine + lopinavir/ritonavir in people with HIV Infections, run by Juan A. Arnaiz at 5 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
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?
Changes in total cholesterol and HDL and LDL fractions (time frame: 48 weeks). 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 NCT00759070, 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 22 Feb 2013.