Trial To Assess The Lipid-Lowering Effect Of Adding Tenofovir/Emtricitabine Co-Formulation Vs Placebo To Hiv-1-Infected Subjects With Dyslipidemia And Sustained Viral Load Suppression Under Monotherapy With Ritonavir-Boosted Protease Inhibitors
Condition: HIV; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This is a phase IV, multicenter,, prospective, randomised, crossover, double blind,
      placebo-controlled and proof of concept clinical trial. The trial was conducted in a total
      sample of 60 patients (30 patients per group), which assures adequate power to detect
      differences. This study is adequate to demonstrate the lipid-lowering effect of TDF/FTC
      co-formulation addition in patients with dyslipidemia and stable monotherapy antiretroviral
      treatment.

      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.

      In Group A the expected changes in cholesterol values, regarding baseline, can be observed 3
      months after TDF/FTC addition. After this, a period of 3 months with placebo will act as a
      washout period, allowing establishing comparisons intra-patient. Finally, another period of 3
      months with placebo will permit to establish comparisons with the first 3-month TDF/FTC
      intervention. In Group B, subjects will follow a 3-month placebo period, later a 3-month
      TDF/FTC intervention and finally a placebo period that will act as a wash-out.

      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.

      The date for the inclusion of the first patient was November 2011 and the end of the last
      patient follow-up has been in February 2014. The enrolment period has been 18 months. The
      final study report will be submitted before November 2014.
    

Intervention name(s): Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TDF/FTC 300/200mg daily during 3 months + Placebo during 6 months; Placebo during 3 months + TDF/FTC 300/200mg daily during 3 months + Placebo during 3 months
Other intervention name(s): N/H; N/H
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lípid-lowering effect; Tenofovir; Dyslipidemia