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Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00759070
Acronym
LIPOTAR-07
Enrollment
50
Registered
2008-09-25
Start date
2008-09-30
Completion date
2013-07-31
Last updated
2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Treatment Naïve

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.

Interventions

DRUGTenofovir + emtricitabine + efavirenz

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) \+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily

DRUGTenofovir + emtricitabine + lopinavir/ritonavir

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
CollaboratorOTHER
Germans Trias i Pujol Hospital
CollaboratorOTHER
Hospital Universitari Joan XXIII de Tarragona.
CollaboratorOTHER
Hospitales Universitarios Virgen del Rocío
CollaboratorOTHER
Juan A. Arnaiz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Changes in total cholesterol and HDL and LDL fractions48 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026