NCT02470650|WithdrawnPhase 4
Study Stopped
No participants enrolled
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
0
0 countries
N/A
Study Start
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 29, 2015
Actual (reported)June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 12, 2015
Actual (reported)July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
48 weeks of initiation antiretroviral treatment
Change in the number of CD4 cells
48 weeks
number of patients with virologic response ratio copies mL plasma viral load)
48 weeks
Change in body composition and mineral density bone lumbar) measurement with DEXA
48 weeks
Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function
48 weeks
Rate of mortality and clinical progression
48 weeks
EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day)
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
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)
Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
elvitegravir/cobicistat/emtricitabine/tenofovir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
abacavir/lamivudine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMallolas
Hospital Clínic
0 participants (actual enrollment reported by the registry).
First Submitted
May 29, 2015
First Posted
June 12, 2015
Study Start
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients
Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day
Ritonavir 100 mg recovered tablet once a day
lamivudine 300mg (Epivir) 1 recovered tablet
rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 30, 2025
Record last verified: 2025-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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