- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458977
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
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08035
- Hospital Valle Hebrón
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Germans Trias I Pujol Hospital
-
Hospitalet de Llobregat, Barcelona, Spain
- Hospital de Bellvitge
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TDF/FTC (3 months) + Placebo (6 months)
|
TDF/FTC 300/200mg daily during 3 months + Placebo during 6 months
Other Names:
|
Placebo Comparator: Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months)
|
Placebo during 3 months + TDF/FTC 300/200mg daily during 3 months + Placebo during 3 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total fasting cholesterol
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
LDL-cholesterol
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD4 cell count
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Changes in liver enzymes
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Changes in phosphate
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Changes in creatinine
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Changes in glomerular filtration rate
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Changes in HDL cholesterol
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Changes in triglycerides
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Adverse events
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Resistance mutations
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
lipid-lowering drugs
Time Frame: Baseline, week 4, 12, 24 and 36
|
Baseline, week 4, 12, 24 and 36
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Other Study ID Numbers
- TULIP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyslipidemia
-
Kowa Research Institute, Inc.CompletedMixed Dyslipidemia | Primary DyslipidemiaUnited States
-
Chong Kun Dang PharmaceuticalCompletedDyslipidemia (Fredrickson Type Ⅱa) | Dyslipidemia (Fredrickson Type Ⅱb)Korea, Republic of
-
Hanlim Pharm. Co., Ltd.RecruitingMixed DyslipidemiaKorea, Republic of
-
IlDong Pharmaceutical Co LtdNot yet recruiting
-
Arrowhead PharmaceuticalsCompletedMixed DyslipidemiaUnited States, Australia, Poland, New Zealand, Canada, Hungary
-
Provident Clinical ResearchReliant PharmaceuticalsCompleted
-
Arrowhead PharmaceuticalsActive, not recruitingMixed DyslipidemiaUnited States, Australia, Canada, New Zealand
-
Yooyoung Pharmaceutical Co., Ltd.CompletedCombined DyslipidemiaKorea, Republic of
-
Société des Produits Nestlé (SPN)CompletedPrimary DyslipidemiaChina
-
Provident Clinical ResearchReliant PharmaceuticalsUnknown
Clinical Trials on Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)
-
Merck Sharp & Dohme LLCCompleted
-
University of Colorado, DenverCompletedHealthy Volunteers | Pharmacokinetics
-
University of California, San DiegoActive, not recruitingHiv | Hormone TherapyUnited States
-
University of California, San FranciscoSan Francisco AIDS Foundation; California HIV/AIDS Research ProgramCompletedHIV Prevention | Transgender HealthUnited States
-
Centers for Disease Control and PreventionBotswana Ministry of HealthCompleted
-
David A Wohl, MDMerck Sharp & Dohme LLCCompletedHIV InfectionsUnited States
-
Centers for Disease Control and PreventionGilead Sciences; Botswana Ministry of HealthCompleted
-
Thai Red Cross AIDS Research CentreRecruiting
-
Merck Sharp & Dohme LLCCompleted
-
Chinese University of Hong KongCompleted