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Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism (LIPOTAR-07)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
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
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00759070
First received: September 23, 2008
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Tenofovir + emtricitabine + efavirenz Drug: Tenofovir + emtricitabine + lopinavir/ritonavir | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Efavirenz
Ritonavir
Lopinavir
Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Changes in total cholesterol and HDL and LDL fractions [ Time Frame: 48 weeks ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
|
Drug: Tenofovir + emtricitabine + efavirenz
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) + Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily |
|
Active Comparator: 2
Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
|
Drug: Tenofovir + emtricitabine + lopinavir/ritonavir
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759070
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759070
Locations
| Spain | |
| Hospital Germans Trias i Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Clinic | |
| Barcelona, Spain, 08036 | |
| Hospital Universitario Virgen del Rocío | |
| Sevilla, Spain, 41013 | |
| Hospital Joan XXIII | |
| Tarragona, Spain, 43007 | |
Sponsors and Collaborators
Juan A. Arnaiz
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
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00759070 History of Changes |
| Other Study ID Numbers: |
LIPOTAR-07 EudraCT number: 2007-002698-29 |
| Study First Received: | September 23, 2008 |
| Last Updated: | February 21, 2013 |
Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
|
Treatment Naïve |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Ritonavir Efavirenz Emtricitabine Lopinavir Antiviral Agents |
Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers |
ClinicalTrials.gov processed this record on June 22, 2017