NCT01458977

Brief Summary

This is a phase IV, multicenter, prospective, randomised, crossover, double blind, placebo-controlled and proof of concept clinical trial. All subjects fulfilling inclusion criteria will be randomised to add either TDF/FTC co-formulation (group A) or placebo (Group B) to their current PI/r regimen, i.e.: DRV/r 800/100 mg QD or LPV/r 400/100 BID. This will be followed by a crossover addition of TDF/FTC co-formulation or placebo. Randomization will be centralised in the CRO FLS-Research Support and will be stratified by DRV/r or LPV/r intake at baseline to ensure equal distribution in both arms. TDF/FTC co-formulation or Placebo will be provided in a double-blinded fashion, i.e.: neither the treating physician nor the patient will know whether the patient is receiving TDF/FTC or placebo. All subjects will receive dietary counselling to promote lipid-lowering diet provided by a specialised dietician throughout the study. The expected duration of the study for each participant will be 36 weeks. There will be 6 visits: screening, baseline and weeks 4, 12, 24 and 36.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

2.1 years

First QC Date

October 21, 2011

Last Update Submit

June 18, 2014

Conditions

HIVDyslipidemia

Keywords

Lípid-lowering effectTenofovirDyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Total fasting cholesterol

    Baseline, week 4, 12, 24 and 36

  • LDL-cholesterol

    Baseline, week 4, 12, 24 and 36

Secondary Outcomes (10)

  • CD4 cell count

    Baseline, week 4, 12, 24 and 36

  • Changes in liver enzymes

    Baseline, week 4, 12, 24 and 36

  • Changes in phosphate

    Baseline, week 4, 12, 24 and 36

  • Changes in creatinine

    Baseline, week 4, 12, 24 and 36

  • Changes in glomerular filtration rate

    Baseline, week 4, 12, 24 and 36

  • +5 more secondary outcomes

Study Arms (2)

TDF/FTC (3 months) + Placebo (6 months)

EXPERIMENTAL

TDF/FTC (3 months) + Placebo (6 months)

Drug: Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)

Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months)

PLACEBO COMPARATOR

Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months)

Drug: Placebo

Interventions

Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)DRUG

TDF/FTC 300/200mg daily during 3 months + Placebo during 6 months

Also known as: N/H
TDF/FTC (3 months) + Placebo (6 months)
PlaceboDRUG

Placebo during 3 months + TDF/FTC 300/200mg daily during 3 months + Placebo during 3 months

Also known as: N/H
Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months)

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Chronic HIV-1 infection
  • Antiretroviral treatment with either DRV/r (800/100 mg QD) or LPV/r (400/100 mg BID) monotherapy during at least 6 months prior to screening.
  • Fasting total cholesterol or LDL-cholesterol levels ≥ 200 and ≥130 mg/dL respectively, in the previous two consecutive tests obtained at least 4 weeks apart before screening.
  • Calculated creatinine clearance ≥ 60 mL/min, according to the Cockcroft-Gault formula.
  • Undetectable plasma HIV-1 RNA levels (\< 50 copies/mL) during at least 6 months prior to screening.
  • Adequate treatment adherence.
  • Absence of TDF or FTC resistances.
  • Written informed consent to participate into the study.

You may not qualify if:

  • Lactating, pregnancy or fertile women willing to be pregnant.
  • Concomitant use of any drug with potential drug-drug interaction with DRV/r, LPV/r or TDF/FTC co-formulation at study entry.
  • Concomitant use of any lipid-lowering drugs at study entry.
  • Prior documented intolerance or hypersensitivity to TDF, FTC, LPV/r or DRV/r.
  • Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
  • Acute or chronic renal documented pathologies.
  • Documented resistance to any of the study drugs (either genotypic or phenotypic)
  • Life expectancy less or equal to 1 year.
  • Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
  • Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopped for more than 12 weeks.
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital Valle Hebrón

Barcelona, Barcelona, 08035, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Related Publications (1)

  • Santos JR, Saumoy M, Curran A, Bravo I, Llibre JM, Navarro J, Estany C, Podzamczer D, Ribera E, Negredo E, Clotet B, Paredes R; Tenofovir/emtricitabine inflUence on LIPid metabolism (TULIP) Study Group. The lipid-lowering effect of tenofovir/emtricitabine: a randomized, crossover, double-blind, placebo-controlled trial. Clin Infect Dis. 2015 Aug 1;61(3):403-8. doi: 10.1093/cid/civ296. Epub 2015 Apr 13.

    PMID: 25870325DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 25, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

ES(3)