Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism (LIPOTAR-07)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00759070 |
Recruitment Status
: Unknown
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was: Active, not recruiting
First Posted
: September 25, 2008
Last Update Posted
: February 22, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Tenofovir + emtricitabine + efavirenz Drug: Tenofovir + emtricitabine + lopinavir/ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects |
Study Start Date : | September 2008 |
Estimated Primary Completion Date : | July 2013 |
Estimated Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- Changes in total cholesterol and HDL and LDL fractions [ Time Frame: 48 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759070
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 |
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 |
First Posted: | September 25, 2008 Key Record Dates |
Last Update Posted: | February 22, 2013 |
Last Verified: | February 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 Ritonavir Lopinavir Tenofovir Emtricitabine Efavirenz HIV Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers |