Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism (LIPOTAR-07)
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Tenofovir + emtricitabine + efavirenz
Tenofovir + emtricitabine + lopinavir/ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naïve
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Current treatment for hepatitis C coinfection
- Diabetes mellitus (fasting glycemia > 124 mg/dL)
- Illegal drug use or alcohol abuse
- Active AIDS-defining opportunistic disease
Sites / Locations
- Hospital Germans Trias i Pujol
- Hospital de la Santa Creu i Sant Pau
- Hospital Clinic
- Hospital Universitario Virgen del Rocío
- Hospital Joan XXIII
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
Outcomes
Primary Outcome Measures
Changes in total cholesterol and HDL and LDL fractions
Secondary Outcome Measures
Full Information
NCT ID
NCT00759070
First Posted
September 23, 2008
Last Updated
February 21, 2013
Sponsor
Juan A. Arnaiz
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
1. Study Identification
Unique Protocol Identification Number
NCT00759070
Brief Title
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
Acronym
LIPOTAR-07
Official Title
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Naïve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
Intervention Type
Drug
Intervention Name(s)
Tenofovir + emtricitabine + efavirenz
Intervention Description
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)
+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily
Intervention Type
Drug
Intervention Name(s)
Tenofovir + emtricitabine + lopinavir/ritonavir
Intervention Description
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID
Primary Outcome Measure Information:
Title
Changes in total cholesterol and HDL and LDL fractions
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Current treatment for hepatitis C coinfection
Diabetes mellitus (fasting glycemia > 124 mg/dL)
Illegal drug use or alcohol abuse
Active AIDS-defining opportunistic disease
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29683854
Citation
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.
Results Reference
derived
PubMed Identifier
25155608
Citation
Egana-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.
Results Reference
derived
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Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
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