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
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Dyslipidemia |
Drug: Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine) Drug: Placebo |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Official Title: | Prospective, Randomised, Crossover, Double-Blind, Placebo-Controlled 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 |
- Total fasting cholesterol [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- LDL-cholesterol [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- CD4 cell count [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: No ]
- Changes in liver enzymes [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- Changes in phosphate [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- Changes in creatinine [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- Changes in glomerular filtration rate [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- Changes in HDL cholesterol [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- Changes in triglycerides [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
- Resistance mutations [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: No ]
- lipid-lowering drugs [ Time Frame: Baseline, week 4, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 60 |
Study Start Date: | January 2012 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: TDF/FTC (3 months) + Placebo (6 months)
TDF/FTC (3 months) + Placebo (6 months)
|
Drug: Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)
TDF/FTC 300/200mg daily during 3 months + Placebo during 6 months
Other Name: N/H
|
Placebo Comparator: Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months)
Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months)
|
Drug: Placebo
Placebo during 3 months + TDF/FTC 300/200mg daily during 3 months + Placebo during 3 months
Other Name: N/H
|
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 date for the inclusion of the first patient is November 2011 and the end of the last patient follow-up will be approximately in September 2013. The expected enrollment period is 13 months. The final study report will be submitted before June 2014.
![](https://webarchive.library.unt.edu/web/20130305102511im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
- 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.
![](https://webarchive.library.unt.edu/web/20130305102511im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Bonaventura Clotet, MD,PhD | 0034934657897 | bclotet@flsida.org |
Spain | |
Germans Trias i Pujol Hospital | Recruiting |
Badalona, Barcelona, Spain, 08916 | |
Principal Investigator: Bonaventura Clotet, MD,PhD |
![](https://webarchive.library.unt.edu/web/20130305102511im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Fundacio Lluita Contra la SIDA |
ClinicalTrials.gov Identifier: | NCT01458977 History of Changes |
Other Study ID Numbers: | TULIP |
Study First Received: | October 21, 2011 |
Last Updated: | October 18, 2012 |
Health Authority: | Spain: Ministry of Health |
Keywords provided by Fundacio Lluita Contra la SIDA:
Lípid-lowering effect Tenofovir Dyslipidemia |
Additional relevant MeSH terms:
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Protease Inhibitors Ritonavir Tenofovir Tenofovir disoproxil Emtricitabine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2013