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iHIVARNA Clinical Trial in HIV Infected Individuals (iHIVARNA-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02888756
Recruitment Status : Terminated (Interim analysis did not show sufficient immunogenicity of IMP compared to placebo)
First Posted : September 5, 2016
Results First Posted : December 9, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
IrsiCaixa
Institute of Tropical Medicine, Belgium
Vrije Universiteit Brussel
Synapse bv
Asphalion
eTheRNA immunotherapies
CR2O
Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
Universitair Ziekenhuis Brussel
Information provided by (Responsible Party):
Rob Gruters, Erasmus Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Biological: iHIVARNA-01
Biological: TriMix
Biological: Placebo
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Period Title: Vaccination Period
Started 16 9 8
Completed 16 9 8
Not Completed 0 0 0
Period Title: Analytical Treatment Interruption
Started [1] 15 9 8
Completed 5 3 3
Not Completed 10 6 5
Reason Not Completed
Physician Decision             10             6             5
[1]
One participant did not start treatment interruption
Arm/Group Title iHIVARNA-01 TriMix Placebo Total
Hide Arm/Group Description

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Total of all reporting groups
Overall Number of Baseline Participants 16 9 8 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 9 participants 8 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
9
 100.0%
8
 100.0%
33
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 9 participants 8 participants 33 participants
Female
1
   6.3%
0
   0.0%
0
   0.0%
1
   3.0%
Male
15
  93.8%
9
 100.0%
8
 100.0%
32
  97.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 16 participants 9 participants 8 participants 33 participants
1 1 0 2
Belgium Number Analyzed 16 participants 9 participants 8 participants 33 participants
6 3 3 12
Spain Number Analyzed 16 participants 9 participants 8 participants 33 participants
9 5 5 19
CD4 T cell counts  
Median (Inter-Quartile Range)
Unit of measure:  Cells/microliter
Number Analyzed 16 participants 9 participants 8 participants 33 participants
793
(689 to 1041)
708
(592 to 961)
742
(679 to 918)
769
(664 to 974)
1.Primary Outcome
Title Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Hide Description
  • Grade 3 or above local adverse event (pain, cutaneous reactions including induration).
  • Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia).
  • Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively.

Any event attributable to vaccination leading to discontinuation of the immunisation regimen.

Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 16 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Immunogenicity as Measured by Elispot
Hide Description Change from baseline immunogenicity as measured by ELISPOT at week 6 and 18, i.e. two weeks and 14 weeks after the last immunization compared to both control groups
Time Frame week 6 and week 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 16 9 8
Mean (95% Confidence Interval)
Unit of Measure: delta log difference spot forming units
week 6
-0.07
(-0.35 to 0.20)
0.18
(-0.17 to 0.52)
0.01
(-0.57 to 0.60)
week 18
-0.08
(-0.57 to 0.42)
-0.12
(-0.61 to 0.36)
0.45
(-0.52 to 1.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iHIVARNA-01, TriMix, Placebo
Comments Analyzed for week 6, to provide statistical information for decision on execution of intracellular cytokine staining (ICS).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Immunogenicity as Measured by Intracellular Cytokine Staining (ICS)
Hide Description HIV-specific CD4+ and CD8+ T cell responses after immunization by the number of poly-functional T cells as determined by intracellular cytokine staining, (ICS).
Time Frame week 10, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
The data were not collected. In the protocol it was pre-specified, that ICS would not be done if Elispot results did not show immunogenicity of the study product. This analysis was not performed, because the results from the Elispot assay at the same time points showed no increase in the number of spot-forming units, also see primary outcome two.
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Viral Rebound
Hide Description time until viral rebound (defined as two consecutive measurements of plasma viral load > 1000 copies/mL separated by at least 15 days) after discontinuation at week 6.
Time Frame week 6-18
Hide Outcome Measure Data
Hide Analysis Population Description
One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 15 9 8
Median (95% Confidence Interval)
Unit of Measure: days
50
(33 to 57)
55.5
(43 to 77)
58
(36 to 72)
5.Secondary Outcome
Title Change in Plasma Viral Load
Hide Description difference in log10 copies/ml plasma viral load in vivo after analytical treatment interruption (ATI, week 6-restart ART), compared to placebo WFI
Time Frame week 6-18
Hide Outcome Measure Data
Hide Analysis Population Description
One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 15 9 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: log10 copies/ml
-0.17
(-1.10 to 0.77)
-0.14
(-1.18 to 0.90)
1.26
(0.21 to 2.31)
6.Secondary Outcome
Title Functional Cure
Hide Description proportion of patients with viral load below detectable level of 50 copies/mL in plasma after ATI, week 18
Time Frame week 18
Hide Outcome Measure Data
Hide Analysis Population Description
One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 15 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0
7.Secondary Outcome
Title Primary Immune Response Against Vaccine
Hide Description Change in frequency of at least 0.7log10 HIV-specific T-cell responses between baseline and week 6
Time Frame from baseline to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 13 7 6
Mean (95% Confidence Interval)
Unit of Measure: delta log spot forming units
0.01
(-0.56 to 0.57)
0.17
(-0.47 to 0.81)
2.65
(1.94 to 3.37)
8.Secondary Outcome
Title CD8 T Cell Mediated Viral Suppression
Hide Description The capacity of CD8 T cells to suppress virus production in HIV infected autologous CD4 T cells, after vaccination. For this purpose PBMC are isolated and separated in CD8 and CD4 T cells. CD4 cells are infected with HIV. Thereafter CD4 cells are co-cultured with pre-stimulated CD8 cells and the capacity to suppress virus production at different effector to target (E:T) ratios is measured, by the change of p24 Gag production. Pannus et al AIDS 2019, PMID: 30702513
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 10 9 5
Mean (95% Confidence Interval)
Unit of Measure: log(pg/ml)
stimulated (E:T) 2:1
0.15
(-0.69 to 0.99)
0.22
(-0.73 to 1.16)
0.18
(-0.48 to 0.85)
Stimulated (E:T) 0.1:1
-0.65
(-1.26 to -0.05)
-1.32
(-2.00 to -0.65)
0.41
(-0.08 to 0.90)
9.Secondary Outcome
Title Proviral DNA Reservoir
Hide Description effect on reservoir as measured by changes in the proviral DNA copy numbers per million cells during and after immunization
Time Frame day 0-90 (week 4, week 4 + 1 day and week 5 and week 6) and day 90-130 (week 18) and day >130 (week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 16 9 8
Mean (95% Confidence Interval)
Unit of Measure: delta log copies DNA /10E6 cel
proviral DNA 0-90 days
-0.002
(-0.007 to 0.003)
-0.001
(-0.007 to 0.004)
0.007
(0.003 to 0.011)
proviral DNA 90-130 days
0.004
(-0.010 to 0.019)
0.004
(-0.013 to 0.020)
-0.003
(-0.015 to 0.008)
proviral DNA >130 days
-0.001
(-0.007 to 0.005)
-0.002
(-0.010 to 0.006)
-0.003
(-0.007 to 0.002)
10.Secondary Outcome
Title Viral Immune Escape
Hide Description viral immune escape: change in % mutated epitopes from pre-cART to post-ATI
Time Frame week 18
Hide Outcome Measure Data
Hide Analysis Population Description
data were not collected
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Transcriptomics
Hide Description host protein mRNA expression profiles in whole blood
Time Frame week 6 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
data were not collected
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Cell-associated RNA Viral Reservoir
Hide Description effect on reservoir as measured by changes in the intracellular viral RNA copy numbers per million cells during and after immunization
Time Frame day 0-30 (week 4, week 4 + 1 day and week 5) and day 30-80 (week 6), 80-150 days (week 18) and >150 days (week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description:

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

Overall Number of Participants Analyzed 16 9 8
Mean (95% Confidence Interval)
Unit of Measure: delta log copies RNA/ml
caRNA 0-30 days
-0.001
(-0.009 to 0.007)
-0.002
(-0.012 to 0.008)
-0.004
(-0.011 to 0.003)
caRNA 30-80 days
-0.006
(-0.015 to 0.003)
-0.001
(-0.014 to 0.010)
0.032
(0.024 to 0.040)
caRNA 80-150 days
0.002
(-0.008 to 0.012)
0.003
(-0.008 to 0.015)
-0.016
(-0.024 to -0.008)
caRNA >150 days
0.002
(-0.008 to 0.011)
-0.001
(-0.012 to 0.010)
-0.004
(-0.011 to 0.003)
Time Frame 30 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title iHIVARNA-01 TriMix Placebo
Hide Arm/Group Description

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption

TriMix: Therapeutic vaccination, followed by treatment interruption

Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval

TriMix: Therapeutic vaccination, followed by treatment interruption

Water for injection 3 vaccinations, two weeks interval

Placebo: Therapeutic vaccination, followed by treatment interruption

All-Cause Mortality
iHIVARNA-01 TriMix Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/9 (0.00%)      0/8 (0.00%)    
Hide Serious Adverse Events
iHIVARNA-01 TriMix Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      0/9 (0.00%)      1/8 (12.50%)    
Gastrointestinal disorders       
Colitis * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Pancreatitis * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Psychiatric disorders       
Depression * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
iHIVARNA-01 TriMix Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/16 (100.00%)      9/9 (100.00%)      8/8 (100.00%)    
Blood and lymphatic system disorders       
Lymphadenopathy * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1
Ear and labyrinth disorders       
Vertigo * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Eye disorders       
Vitreous floaters * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders       
Anal fissure * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Aphthous ulcer * 1  1/16 (6.25%)  2 0/9 (0.00%)  0 0/8 (0.00%)  0
Diarrhoea * 1  1/16 (6.25%)  1 4/9 (44.44%)  4 2/8 (25.00%)  2
Dry mouth * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Dyspepsia * 1  1/16 (6.25%)  1 1/9 (11.11%)  1 1/8 (12.50%)  1
Dysphagia * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Entercolitis * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1
Food poisoning * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Nausea * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 2/8 (25.00%)  3
Esophageal pain * 1  2/16 (12.50%)  2 0/9 (0.00%)  0 1/8 (12.50%)  1
Oral dysaesthesia * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Vomiting * 1  1/16 (6.25%)  1 1/9 (11.11%)  1 1/8 (12.50%)  1
General disorders       
Asthenia * 1  1/16 (6.25%)  1 1/9 (11.11%)  1 1/8 (12.50%)  1
Chills * 1  2/16 (12.50%)  2 1/9 (11.11%)  2 1/8 (12.50%)  2
Cyst * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Fatigue * 1  2/16 (12.50%)  3 3/9 (33.33%)  5 2/8 (25.00%)  4
influenza-like illness * 1  1/16 (6.25%)  2 1/9 (11.11%)  1 0/8 (0.00%)  0
Infusion site extravasation * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  2
Injection site pain * 1  3/16 (18.75%)  3 2/9 (22.22%)  3 2/8 (25.00%)  4
Injection site puritis * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  2
Injection site reaction * 1  1/16 (6.25%)  1 1/9 (11.11%)  1 0/8 (0.00%)  0
Malaise * 1  3/16 (18.75%)  6 1/9 (11.11%)  1 1/8 (12.50%)  2
Pyrexia * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1
Tenderness * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Urethritis * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Immune system disorders       
Hypersensitivity * 1  1/16 (6.25%)  3 0/9 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations       
Conjunctivitis * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Eyelid infection * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Furunkel * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Gastro enteritis * 1  2/16 (12.50%)  2 0/9 (0.00%)  0 0/8 (0.00%)  0
Gingivitis * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Hepatitis viral * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Influenza * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Laryngitis * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Lung infection * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Oral herpes * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Respiratory tract infection * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Sexually transmitted disease * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Sinusitis * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Skin infection * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  2
Tonsillitis * 1  1/16 (6.25%)  2 0/9 (0.00%)  0 0/8 (0.00%)  0
Upper respiratory tract infection * 1  2/16 (12.50%)  2 1/9 (11.11%)  1 0/8 (0.00%)  0
Urinary tract infection * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Viral upper respiratory tract infection * 1  4/16 (25.00%)  5 0/9 (0.00%)  0 1/8 (12.50%)  1
Injury, poisoning and procedural complications       
Accidental exposure to product * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Ligament sprain * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
wrist fracture * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Investigations       
Blood creatine-phospho kinase increased * 1  2/16 (12.50%)  2 0/9 (0.00%)  0 1/8 (12.50%)  1
Metabolism and nutrition disorders       
Gout * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Hypoglycemia * 1  1/16 (6.25%)  2 0/9 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Althragia * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Back pain * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Groin pain * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Muscles spasms * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Myalgia * 1  5/16 (31.25%)  6 1/9 (11.11%)  1 2/8 (25.00%)  5
Neck pain * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders       
Aphasia * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Disturbance in attention * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2
Dizziness * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  2
Headache * 1  6/16 (37.50%)  7 1/9 (11.11%)  1 4/8 (50.00%)  8
Hypoaesthesia * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2
Muscle contractions involuntary * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Neuralgia * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Somnolence * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Syncope * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Psychiatric disorders       
Anxiety * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Burn-out syndrome * 1  0/16 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0
Depression * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1
Insomnia * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1
Mental disoreder * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Nightmare * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Renal and urinary disorders       
Haematuria * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Reproductive system and breast disorders       
Balanoposthitis * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Erectile dysfunction * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2
Dysphonia * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Productive cough * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders       
Eczema * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Erythemia * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1
Night sweats * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1
Pruritis * 1  1/16 (6.25%)  1 1/9 (11.11%)  2 0/8 (0.00%)  0
Rash macular * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Skin swelling * 1  0/16 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1
Skin ulcer * 1  1/16 (6.25%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Vascular disorders       
hypotensions * 1  0/16 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Limited number of subjects for statistical analysis due to early termination. There was an error in the study product, see https://insights.ovid.com/pubmed?pmid=31490219
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr R.A. Gruters
Organization: Erasmus MC
Phone: +31 10 7032100
EMail: r.gruters@erasmusmc.nl
Layout table for additonal information
Responsible Party: Rob Gruters, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02888756    
Other Study ID Numbers: iHIVARNA phase II
2016-002724-83 ( EudraCT Number )
First Submitted: August 23, 2016
First Posted: September 5, 2016
Results First Submitted: October 4, 2019
Results First Posted: December 9, 2019
Last Update Posted: December 23, 2019