Patient CompliancePhase 4NCT02470650
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive
A Phase 4 study testing elvitegravir/cobicistat/emtricitabine/tenofovir, Darunavir and abacavir/lamivudine in people with Patient Compliance and Antiretroviral Therapy Intolerance, run by Juan A. Arnaiz.
Trial summary
The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patient Compliance, Antiretroviral Therapy Intolerance
- What is being tested?
- elvitegravir/cobicistat/emtricitabine/tenofovir, Darunavir and abacavir/lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2017
- 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
- 1-negative pregnancy test in women of childbearing age
- 2- stable HIV-1 infection clinically and not take antiretroviral therapy
- 3- viral load HIV <100,000 copies
- 4- CD4 cells >100 cels/mm3
- 5- Glomerular filtration >70mlmin
- 6- have a negative HLA B5701
- 7-.patients should have given informed written consent
- 8- in the opinion of the investigator, be able to follow the design of the Protocol visits
Who cannot join
- 1-. Patients who had virologic failure with any antiretroviral therapy
- 2- evidence of prior mutations of the study drugs
- 3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study
- 4- contraindication to the drugs study
- 5- any condition that does not allow to ensure the correct compliance to the study
- 6- uncontrolled previous psychiatric illness
- 7- Current or active addiction or alcoholism
About this study
Official title: Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks
The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.
Read the detailed description
Secondary objectives:
- patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)
- Change in the number of CD4 cells at 48 weeks
- Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks
- Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
- Rate of mortality and clinical progression at 48 weeks
- general tolerability and safety: adverse events (AA) and serious AA description
- Being tested
- elvitegravir/cobicistat/emtricitabine/tenofovir, Darunavir, abacavir/lamivudine, Ritonavir, Lamivudine
- Keywords
- comparative effectiveness
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elvitegravir/cobicistat/emtricitabine/tenofovirDrug
Also called Stribild
1 recovered tablet once Per day ● Specify total dose (number and unit): 150 mg de elvitegravir, 150 mg cobicistat, 200 mg emtricitabine , 245 mg tenofovir disoprox milligram(s)
DarunavirDrug
Also called prezista
Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day
abacavir/lamivudineDrug
Also called Kivexa
Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day
RitonavirDrug
Also called Norvir
Ritonavir 100 mg recovered tablet once a day
LamivudineDrug
Also called Epivir
lamivudine 300mg (Epivir) 1 recovered tablet
rilpivirineDrug
Also called Edurant
rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
| Study group | Role | What they receive |
|---|---|---|
| elvitegravir/cobicistat/emtricitabine/tenofovir | Experimental | EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day) Receives: Drug: elvitegravir/cobicistat/emtricitabine/tenofovir |
| darunavir+ritonavir+lamivudine | Active comparator | Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day Receives: Drug: Darunavir; Drug: Ritonavir; Drug: Lamivudine |
| abacavir/lamivudine+rilpivirine | Active comparator | Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day Receives: Drug: abacavir/lamivudine; Drug: rilpivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency (cost-effectiveness)
Antiretroviral treatment effectiveness defined by the number of patients with <37 copies/ml viral load at the 48 weeks and the treatment cost defined by the sum of cost ogfthe antiretroviral treatment and all its consequences (adverse effects, changes of pattern study antiretroviral resistance in case of being necessary, days of sick leave by the patient and hospital admission days) that occur in the 48 weeks. The price of the antiretroviral treatment will be defined by Spanish official price.
Measured: 48 weeks of initiation antiretroviral treatment
Secondary outcomes (4)
Change in the number of CD4 cells
Change in the number of CD4 cells at 48 weeks
Measured: 48 weeks
number of patients with virologic response ratio copies mL plasma viral load)
less than 37 copies/mL in plasma viral load
Measured: 48 weeks
Change in body composition and mineral density bone lumbar) measurement with DEXA
Measurement baseline and at 48 weeks. DEXA Scan (Dual X-ray Absorptiometry) to Measure Bone Health
Measured: 48 weeks
Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function
Defined by creatinine clearance, glomerular filtration rate - eGFR - and renal tubular function at week 48 filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2015 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
- Investigators
- Mallolas, Principal investigator, Hospital Clínic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470650
- Sponsor's protocol ID
- Cost-Effect-Clinic
- Other IDs
- 2014-004820-24, 2014
- Status last verified
- Jul 2025
- First submitted
- 29 May 2015
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks
- ClinicalTrials.gov ID
- NCT02470650
- Acronym / sponsor ID
- Cost-Effect-Clinic
- Keywords
- comparative effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Jun 2015 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 12 Jun 2015 (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.
The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.
Detailed description
Secondary objectives:
- patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)
- Change in the number of CD4 cells at 48 weeks
- Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks
- Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
- Rate of mortality and clinical progression at 48 weeks
- general tolerability and safety: adverse events (AA) and serious AA description
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| elvitegravir/cobicistat/emtricitabine/tenofovir | Experimental | Drug: elvitegravir/cobicistat/emtricitabine/tenofovirEVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day) |
| darunavir+ritonavir+lamivudine | Active comparator | Drug: Darunavir, Drug: Ritonavir, Drug: LamivudineDarunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day |
| abacavir/lamivudine+rilpivirine | Active comparator | Drug: abacavir/lamivudine, Drug: rilpivirineAbacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1-negative pregnancy test in women of childbearing age
- 2- stable HIV-1 infection clinically and not take antiretroviral therapy
- 3- viral load HIV <100,000 copies
- 4- CD4 cells >100 cels/mm3
- 5- Glomerular filtration >70mlmin
Key exclusion criteria (7 listed)
- 1-. Patients who had virologic failure with any antiretroviral therapy
- 2- evidence of prior mutations of the study drugs
- 3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study
- 4- contraindication to the drugs study
- 5- any condition that does not allow to ensure the correct compliance to the study
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 |
|---|---|---|
| elvitegravir/cobicistat/emtricitabine/tenofovirAlso: Stribild1 recovered tablet once Per day ● Specify total dose (number and unit): 150 mg de elvitegravir, 150 mg cobicistat, 200 mg emtricitabine , 245 mg tenofovir disoprox milligram(s) | Drug | elvitegravir/cobicistat/emtricitabine/tenofovir |
| DarunavirAlso: prezistaDarunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day | Drug | darunavir+ritonavir+lamivudine |
| abacavir/lamivudineAlso: KivexaAbacavir 600 mg /lamivudine 300 mg recovered tablet once a day | Drug | abacavir/lamivudine+rilpivirine |
| RitonavirAlso: NorvirRitonavir 100 mg recovered tablet once a day | Drug | darunavir+ritonavir+lamivudine |
| LamivudineAlso: Epivirlamivudine 300mg (Epivir) 1 recovered tablet | Drug | darunavir+ritonavir+lamivudine |
| rilpivirineAlso: Edurantrilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day | Drug | abacavir/lamivudine+rilpivirine |
Primary outcome
efficiency (cost-effectiveness)
Time frame: 48 weeks of initiation antiretroviral treatment
Antiretroviral treatment effectiveness defined by the number of patients with <37 copies/ml viral load at the 48 weeks and the treatment cost defined by the sum of cost ogfthe antiretroviral treatment and all its consequences (adverse effects, changes of pattern study antiretroviral resistance in case of being necessary, days of sick leave by the patient and hospital admission days) that occur in the 48 weeks. The price of the antiretroviral treatment will be defined by Spanish official price.
4 secondary outcomes
Change in the number of CD4 cells
Time frame: 48 weeks
number of patients with virologic response ratio copies mL plasma viral load)
Time frame: 48 weeks
Change in body composition and mineral density bone lumbar) measurement with DEXA
Time frame: 48 weeks
Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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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.
Mallolas principal investigator
Hospital Clínic
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing elvitegravir/cobicistat/emtricitabine/tenofovir, Darunavir and abacavir/lamivudine in people with Patient Compliance and Antiretroviral Therapy Intolerance, run by Juan A. Arnaiz.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
efficiency (cost-effectiveness) (time frame: 48 weeks of initiation antiretroviral treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.