Clinical Trial Results:
PILOT STUDY TO ASSESS THE SAFETY AND EFICACY OF SWITCHING THE NNRTI OR PI TO MARAVIROC IN HIV-1-INFECTED SUBJECTS WITH PERSISTENT VIREMIA SUPPRESSION EXPERIENCING NNRTI OR PI-RELATED DYSLIPEMIA
Summary
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EudraCT number |
2009-011868-11 |
Trial protocol |
ES |
Global end of trial date |
21 May 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jan 2020
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First version publication date |
26 Jan 2020
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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 |
MARAVI-SWITCH
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00966329 | ||
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 |
Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA, 34 93 497 84 14, sgel@flsida.org
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Scientific contact |
Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA, 34 93 497 84 14,
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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 |
21 May 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 May 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
21 May 2012
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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 compare the rates of virological suppression <50 copies/mL in subjects switching to MRV or remaining on their previous ARV regimen.
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Protection of trial subjects |
not specific
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Oct 2009
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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: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
30
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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 |
30 subjects with R5 HIV-1 were randomized 1:1 to switch the non-nucleoside reverse transcriptase inhibitor or ritonavir-boosted protease inhibitor to maraviroc or to continue the same antiretroviral treatment | ||||||||||||||||||
Pre-assignment
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Screening details |
Eighty HIV-1-infected aviraemic adults on stable antiretroviral treatment for ≥1 year and no antiretroviral drug resistance were screened for the presence of non-R5 HIV by triplicate proviral V3 population sequencing. 37 had non-R5 viruses and 13 did not fulfil the inclusion criteria. | ||||||||||||||||||
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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Control group | ||||||||||||||||||
Arm description |
to continue with the same HAART | ||||||||||||||||||
Arm type |
non-active comparator | ||||||||||||||||||
Investigational medicinal product name |
Atazanavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
300 mg QD
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Investigational medicinal product name |
ritonavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
100 mg
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Investigational medicinal product name |
lopinavir/ritonavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
250mg
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Investigational medicinal product name |
Fosamprenavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
700mg
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Investigational medicinal product name |
efavirenz
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
600mg
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Investigational medicinal product name |
nevirapine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Ocular use
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Dosage and administration details |
400mg
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Arm title
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Experimental group | ||||||||||||||||||
Arm description |
to switch from the NNRTI/PI to maraviroc during 48 weeks. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Maraviroc
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
300 mg BiD
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Baseline characteristics reporting groups
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Reporting group title |
Control group
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Reporting group description |
to continue with the same HAART | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Experimental group
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Reporting group description |
to switch from the NNRTI/PI to maraviroc during 48 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Control group
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Reporting group description |
to continue with the same HAART | ||
Reporting group title |
Experimental group
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Reporting group description |
to switch from the NNRTI/PI to maraviroc during 48 weeks. |
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End point title |
HIV-1 RNA <50 copies/mL | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 48
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Statistical analysis title |
Comparing proportions | |||||||||
Statistical analysis description |
comparing proportions between groups Week 48
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Comparison groups |
Control group v Experimental group
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
> 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Total Cholesterol | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline to week 48
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No statistical analyses for this end point |
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End point title |
HDL cholesterol | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline to week 48
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No statistical analyses for this end point |
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End point title |
LDL cholesterol | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline to week 48
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No statistical analyses for this end point |
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End point title |
CD4+ T cells | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline to wk48
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Statistical analysis title |
Comparing between groups | ||||||||||||||||||
Statistical analysis description |
Week 48
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Comparison groups |
Control group v Experimental group
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||||
P-value |
= 0.085 | ||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||
Confidence interval |
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End point title |
Triglycerides | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from baseline to wk48
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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 week 48
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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 |
Experimental 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 May 2009 |
Primary endpoint modified |
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25 Nov 2009 |
1. new study title
2. lipid profile as secondary endpoint
3. exclusion criteria deleted
4. study medcation provided by the sponsor
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16 Feb 2010 |
principal investigator switch |
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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 |