NCT00759070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

4.8 years

First QC Date

September 23, 2008

Last Update Submit

February 21, 2013

Conditions

HIV Infections

Keywords

Treatment Naïve

Outcome Measures

Primary Outcomes (1)

  • Changes in total cholesterol and HDL and LDL fractions

    48 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)

Drug: Tenofovir + emtricitabine + efavirenz

2

ACTIVE COMPARATOR

Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)

Drug: Tenofovir + emtricitabine + lopinavir/ritonavir

Interventions

Tenofovir + emtricitabine + efavirenzDRUG

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

1
Tenofovir + emtricitabine + lopinavir/ritonavirDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Hospital Joan XXIII

Tarragona, Tarragona, 43007, Spain

Location

Related Publications (2)

  • 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.

    PMID: 29683854DERIVED

  • 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.

    PMID: 25155608DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirEmtricitabineefavirenzLopinavirRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPyrimidinonesThiazolesSulfur CompoundsAzoles

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

ES(5)