HIVPhase 4NCT01458977
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
A Phase 4 study testing Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine) in people with HIV and Dyslipidemia, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV, Dyslipidemia
- What is being tested?
- Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2012to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate treatment adherence.
- Absence of TDF or FTC resistances.
- Written informed consent to participate into the study.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Hospital Valle Hebrón
Barcelona, Barcelona, 08035
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- HIV, Dyslipidemia
- Being tested
- Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine), Placebo
- Keywords
- Lípid-lowering effect, Tenofovir, Dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)Drug
Also called N/H
TDF/FTC 300/200mg daily during 3 months + Placebo during 6 months
PlaceboDrug
Also called N/H
Placebo during 3 months + TDF/FTC 300/200mg daily during 3 months + Placebo during 3 months
| Study group | Role | What they receive |
|---|---|---|
| TDF/FTC (3 months) + Placebo (6 months) | Experimental | TDF/FTC (3 months) + Placebo (6 months) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fasting cholesterol
Measured: Baseline, week 4, 12, 24 and 36
LDL-cholesterol
Measured: Baseline, week 4, 12, 24 and 36
Secondary outcomes (10)
CD4 cell count
Measured: Baseline, week 4, 12, 24 and 36
Changes in liver enzymes
Measured: Baseline, week 4, 12, 24 and 36
Changes in phosphate
Measured: Baseline, week 4, 12, 24 and 36
Changes in creatinine
Measured: Baseline, week 4, 12, 24 and 36
Changes in glomerular filtration rate
Measured: Baseline, week 4, 12, 24 and 36
Changes in HDL cholesterol
Measured: Baseline, week 4, 12, 24 and 36
Changes in triglycerides
Measured: Baseline, week 4, 12, 24 and 36
Adverse events
Measured: Baseline, week 4, 12, 24 and 36
Resistance mutations
Measured: Baseline, week 4, 12, 24 and 36
lipid-lowering drugs
Measured: Baseline, week 4, 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458977
- Sponsor's protocol ID
- TULIP
- Status last verified
- Jun 2014
- First submitted
- 21 Oct 2011
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25870325
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01458977
- Acronym / sponsor ID
- TULIP
- Conditions
- HIV, Dyslipidemia
- Keywords
- Lípid-lowering effect, Tenofovir, Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF/FTC (3 months) + Placebo (6 months) | Experimental | Drug: Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)TDF/FTC (3 months) + Placebo (6 months) |
| Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months) | Placebo comparator | Drug: PlaceboPlacebo (3 months) + TDF/FTC (3 months) + Placebo (3 months) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)Also: N/HTDF/FTC 300/200mg daily during 3 months + Placebo during 6 months | Drug | TDF/FTC (3 months) + Placebo (6 months) |
| PlaceboAlso: N/HPlacebo during 3 months + TDF/FTC 300/200mg daily during 3 months + Placebo during 3 months | Drug | Placebo (3 months) + TDF/FTC (3 months) + Placebo (3 months) |
Primary outcome
Total fasting cholesterol
Time frame: Baseline, week 4, 12, 24 and 36
LDL-cholesterol
Time frame: Baseline, week 4, 12, 24 and 36
10 secondary outcomes
CD4 cell count
Time frame: Baseline, week 4, 12, 24 and 36
Changes in liver enzymes
Time frame: Baseline, week 4, 12, 24 and 36
Changes in phosphate
Time frame: Baseline, week 4, 12, 24 and 36
Changes in creatinine
Time frame: Baseline, week 4, 12, 24 and 36
Changes in glomerular filtration rate
Time frame: Baseline, week 4, 12, 24 and 36
Changes in HDL cholesterol
Time frame: Baseline, week 4, 12, 24 and 36
Changes in triglycerides
Time frame: Baseline, week 4, 12, 24 and 36
Adverse events
Time frame: Baseline, week 4, 12, 24 and 36
Resistance mutations
Time frame: Baseline, week 4, 12, 24 and 36
lipid-lowering drugs
Time frame: Baseline, week 4, 12, 24 and 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Derived from this study: PubMed 25870325Santos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine) in people with HIV and Dyslipidemia, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fasting cholesterol (time frame: Baseline, week 4, 12, 24 and 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.