Clinical Trial Results:
MULTICENTRE STUDY TO ASSESS CHANGES IN BONE MINERAL DENSITY OF THE SWITCH FROM PROTEASE INHIBITORS TO DOLUTEGRAVIR IN HIV-1-INFECTED SUBJECTS WITH LOW BONE MINERAL DENSITY
Summary
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EudraCT number |
2013-000547-85 |
Trial protocol |
ES |
Global end of trial date |
28 Oct 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Mar 2017
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First version publication date |
19 Mar 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
OSTEODOLU
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02577042 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fundació Lluita contra la SIDA
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Sponsor organisation address |
Crta de Canyet s/n, Badalona, Spain, 08916
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Public contact |
Clinical Research Associates, Fundació Lluita contra la SIDA, +34 93497 84 14, jtoro@fls-rs.com
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Scientific contact |
Clinical Research Associates, Fundació Lluita contra la SIDA, +34 93497 84 14, jtoro@fls-rs.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Mar 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Oct 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate changes in BMD 48 weeks after the switch from a PI to dolutegravir in HIV-infected patients with low bone mineral density.
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Protection of trial subjects |
not specific
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 73
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Worldwide total number of subjects |
73
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EEA total number of subjects |
73
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
73
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Candidates were HIV-infected adults who had been receiving a stable antiretroviral combination including abacavir/lamivudine (Kivexa) plus a ritonavir-boosted PI for at least 6 months. | |||||||||||||||||||||
Pre-assignment
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Screening details |
Seventy-five subjects were screened. | |||||||||||||||||||||
Period 1
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Period 1 title |
overall (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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PI group | |||||||||||||||||||||
Arm description |
ritonavir-boosted PI plus co-formulated lamivudine/abacavir (Kivexa) | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
LPV/r
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
daily
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Investigational medicinal product name |
ATV/r
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
daily
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Investigational medicinal product name |
DRV/r
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
800/100mg once daily in all patients but one, who received 600/100mg every 12 h.
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Investigational medicinal product name |
FosAPV/r
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
daily
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Investigational medicinal product name |
abacavir/ lamivudine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
600mg/300mg once daily
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Arm title
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DOLU group | |||||||||||||||||||||
Arm description |
dolutegravir 50mg plus co-formulated lamivudine/abacavir (Kivexa) every 24h | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
lamivudine/abacavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
600mg/300mg every 24h
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Investigational medicinal product name |
dolutegravir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
50mg every 24h
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Baseline characteristics reporting groups
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Reporting group title |
PI group
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Reporting group description |
ritonavir-boosted PI plus co-formulated lamivudine/abacavir (Kivexa) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
DOLU group
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Reporting group description |
dolutegravir 50mg plus co-formulated lamivudine/abacavir (Kivexa) every 24h | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PI group
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Reporting group description |
ritonavir-boosted PI plus co-formulated lamivudine/abacavir (Kivexa) | ||
Reporting group title |
DOLU group
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Reporting group description |
dolutegravir 50mg plus co-formulated lamivudine/abacavir (Kivexa) every 24h |
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End point title |
evaluate the effect on BMD of switching from a ritonavir-boosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Femoral neck BMD) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
from baseline to wk48
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Statistical analysis title |
Comparing medians | ||||||||||||
Comparison groups |
PI group v DOLU group
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.29 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
evaluate the effect on BMD of switching from a ritonavir-boosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Trochanter BMD) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
from baseline to week 48
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Statistical analysis title |
Comparing medians | ||||||||||||
Comparison groups |
PI group v DOLU group
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.63 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
evaluate the effect on BMD of switching from a ritonavirboosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Total femur BMD) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
from baseline to week 48
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Statistical analysis title |
Comparing medians | ||||||||||||
Comparison groups |
PI group v DOLU group
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.56 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
evaluate the effect on BMD of switching from a ritonavirboosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Lumbar spine BMD) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
from baseline to week 48
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Statistical analysis title |
Comparing medians | ||||||||||||
Comparison groups |
PI group v DOLU group
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.29 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
assess the antiviral efficacy of the switch | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at week 48
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
from baseline to wk48
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
DAIDS AE GRADING TAB | |||||||||||||||||||||||||||||||||
Dictionary version |
1.0
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Reporting groups
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Reporting group title |
PI group
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
DOLU group
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Sep 2013 |
Changes in the supply, packaging, labeling and storage of the investigational product |
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04 Feb 2014 |
Changes in the Informed Consent Information Sheet |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |