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Analytical Treatment Interruption in HIV Positive Patients (ISALA)

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: NCT02590354
Recruitment Status : Completed
First Posted : October 29, 2015
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
University Hospital, Ghent
Universitair Ziekenhuis Brussel
Saint-Pierre University Hospital
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition HIV-1 Infection
Intervention Other: ART interruption
Enrollment 114
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Interruption
Hide Arm/Group Description

The ART treatment in patients with a very low viral reservoir will be interrupted.

Phase 1: Screening visit for HIV patients. During this visit a blood sample is taken for HIV reservoir analysis. Patients in which the reservoir is below a certain treshold will continue to phase 2 and will have their ART treatment interrupted (treatment interruption period).

Period Title: Phase 1
Started 114
Completed 16
Not Completed 98
Reason Not Completed
Active hepatitis B or C infection             1
Confirmed neutrophil count <1200/µl             1
Detectable level of HIV DNA or caRNA             75
Subject does not want to participate             20
Lost to Follow-up             1
Period Title: Phase 2 - Treatment Interruption
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title All Participants (Both Phase 1 and 2)
Hide Arm/Group Description 114 subjects were screened in phase 1. Only those with a low viral reservoir continued to phase 2 (16 subjects).
Overall Number of Baseline Participants 114
Hide Baseline Analysis Population Description
114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Phase 1 Number Analyzed 114 participants
45.5
(38.0 to 52.0)
Phase 2 Number Analyzed 16 participants
43.5
(38.0 to 54.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
Female
6
   5.3%
Male
108
  94.7%
Phase 2 Number Analyzed 16 participants
Female
1
   6.3%
Male
15
  93.8%
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
Asian
1
   0.9%
Black African
1
   0.9%
White
111
  97.4%
Other: Colombian
1
   0.9%
Phase 2 Number Analyzed 16 participants
Asian
0
   0.0%
Black African
0
   0.0%
White
16
 100.0%
Other: Colombian
0
   0.0%
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Risk group   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
Heterosexual contact
14
  12.3%
Homo/Bisexual contact
95
  83.3%
Transfusion, non-haemophilia related
1
   0.9%
Other: unknown
4
   3.5%
Phase 2 Number Analyzed 16 participants
Heterosexual contact
3
  18.8%
Homo/Bisexual contact
12
  75.0%
Transfusion, non-haemophilia related
0
   0.0%
Other: unknown
1
   6.3%
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Duration of HIV infection (months)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Months
Phase 1 Number Analyzed 114 participants
70.9
(47.0 to 100.8)
Phase 2 Number Analyzed 16 participants
47.2
(33.1 to 75.3)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Duration of HIV infection (years)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Phase 1 Number Analyzed 114 participants
5.9
(3.9 to 8.4)
Phase 2 Number Analyzed 16 participants
3.9
(2.8 to 6.3)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Duration of ART (months)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Months
Phase 1 Number Analyzed 114 participants
51.2
(36.1 to 71.4)
Phase 2 Number Analyzed 16 participants
47.3
(34.4 to 74.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Duration of ART (years)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Phase 1 Number Analyzed 114 participants
4.3
(3.0 to 6.0)
Phase 2 Number Analyzed 16 participants
4.0
(2.9 to 6.2)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Last used ART   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
II + NRTI
49
  43.0%
NNRTI + NRTI
51
  44.7%
PI + NRTI
10
   8.8%
Other
4
   3.5%
Phase 2 Number Analyzed 16 participants
II + NRTI
11
  68.8%
NNRTI + NRTI
4
  25.0%
PI + NRTI
1
   6.3%
Other
0
   0.0%
[1]
Measure Description: II = Integrase Inhibitor; NRTI = Nucleoside Reverse Transcriptase Inhibitor; NNRTI = Non-Nucleoside Reverse Transcriptase Inhibitor; PI = Protease Inhibitor
[2]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
HIV type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
A
3
   2.6%
B
106
  93.0%
C
1
   0.9%
CRF02_AG
4
   3.5%
Phase 2 Number Analyzed 16 participants
A
1
   6.3%
B
15
  93.8%
C
0
   0.0%
CRF02_AG
0
   0.0%
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Nadir CD4 count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/µl
Phase 1 Number Analyzed 114 participants
379.0
(338.0 to 482.0)
Phase 2 Number Analyzed 16 participants
440.5
(342.0 to 500.5)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
ALT   [1] 
Median (Inter-Quartile Range)
Unit of measure:  IU/L
Phase 1 Number Analyzed 114 participants
31.0
(23.0 to 37.0)
Phase 2 Number Analyzed 16 participants
21.5
(17.5 to 29.5)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
AST   [1] 
Median (Inter-Quartile Range)
Unit of measure:  IU/L
Phase 1 Number Analyzed 114 participants
27.0
(21.0 to 31.0)
Phase 2 Number Analyzed 16 participants
21.5
(18.5 to 25.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Neutrophil count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  cells/µL
Phase 1 Number Analyzed 114 participants
3.1
(2.4 to 4.0)
Phase 2 Number Analyzed 16 participants
2.8
(2.1 to 4.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
CD4 count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  cells/µL
Phase 1 Number Analyzed 114 participants
733.0
(645.0 to 891.0)
Phase 2 Number Analyzed 16 participants
758.0
(679.0 to 845.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Creatin   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Phase 1 Number Analyzed 114 participants
1.0
(0.9 to 1.1)
Phase 2 Number Analyzed 16 participants
1.0
(0.9 to 1.1)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Hemoglobin   [1] 
Median (Inter-Quartile Range)
Unit of measure:  g/dL
Phase 1 Number Analyzed 114 participants
15.0
(14.2 to 15.7)
Phase 2 Number Analyzed 16 participants
15.1
(14.5 to 15.9)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
HCVAb   [1] 
Median (Inter-Quartile Range)
Unit of measure:  IU/mL
Phase 1 Number Analyzed 114 participants
1.0
(0.8 to 1.0)
Phase 2 Number Analyzed 16 participants
1.0
(1.0 to 1.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
HBsAb   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
>1000mIU/mL
32
  28.1%
Negative
74
  64.9%
No result
8
   7.0%
Phase 2 Number Analyzed 16 participants
>1000mIU/mL
3
  18.8%
Negative
11
  68.8%
No result
2
  12.5%
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
HBcAb   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
Negative (<0.8 IU/mL)
61
  53.5%
Positive (1.0 IU/mL or more)
38
  33.3%
Grey Zone (0.8-0.99 IU/mL)
3
   2.6%
No result
12
  10.5%
Phase 2 Number Analyzed 16 participants
Negative (<0.8 IU/mL)
7
  43.8%
Positive (1.0 IU/mL or more)
7
  43.8%
Grey Zone (0.8-0.99 IU/mL)
1
   6.3%
No result
1
   6.3%
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
HBsAg   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Phase 1 Number Analyzed 114 participants
Negative
100
  87.7%
Positive
2
   1.8%
No results
12
  10.5%
Phase 2 Number Analyzed 16 participants
Negative
15
  93.8%
Positive
0
   0.0%
No results
1
   6.3%
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Plasma viral load   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  copies/mL
Phase 1 Number Analyzed 114 participants
19.0
(19.0 to 19.0)
Phase 2 Number Analyzed 16 participants
19.0
(19.0 to 19.0)
[1]
Measure Description: A value of 19 means <20 copies/mL (lower limit of detection).
[2]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Platelets   [1] 
Median (Inter-Quartile Range)
Unit of measure:  10^9 cells/L
Phase 1 Number Analyzed 114 participants
232.0
(199.0 to 260.0)
Phase 2 Number Analyzed 16 participants
239.5
(207.5 to 285.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Reservoir CD4 caRNA   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Copies/million CD4+ T-cells
Number Analyzed 16 participants
105.5
(64.0 to 280.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption).
Ultra-sensitive plasma viral load   [1] 
Median (Inter-Quartile Range)
Unit of measure:  copies/mL
Number Analyzed 16 participants
0.3
(0.0 to 2.5)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption).
Viral reservoir assay DNA   [1] 
Median (Inter-Quartile Range)
Unit of measure:  copies/10^6PBMCs
Phase 1 Number Analyzed 114 participants
107.0
(46.0 to 205.0)
Phase 2 Number Analyzed 16 participants
37.5
(11.5 to 55.5)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Viral reservoir assay RNA   [1] 
Median (Inter-Quartile Range)
Unit of measure:  copies/10^6PBMCs
Phase 1 Number Analyzed 16 participants
3.0
(1.0 to 6.0)
Phase 2 Number Analyzed 16 participants
2.0
(0.0 to 3.5)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
Spontaneous VRA CD4   [1] 
Median (Inter-Quartile Range)
Unit of measure:  copies/mL
Number Analyzed 16 participants
1.0
(1.0 to 1.5)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption).
Stimulated VRA CD4   [1] 
Median (Inter-Quartile Range)
Unit of measure:  copies/mL
Number Analyzed 16 participants
1.6
(0.5 to 3.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption).
Spontaneous VRA PBMC   [1] 
Median (Inter-Quartile Range)
Unit of measure:  copies/mL
Number Analyzed 16 participants
0.7
(0.0 to 1.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption).
Stimulated VRA PBMC   [1] 
Median (Inter-Quartile Range)
Unit of measure:  copies/mL
Number Analyzed 16 participants
2.2
(0.9 to 3.0)
[1]
Measure Analysis Population Description: 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption).
1.Primary Outcome
Title Assessment of the Number of Participants With a HIV Plasma Viral Load Below the Lower Limit of Detection 48 Weeks Following Interruption of Antiretroviral Treatment
Hide Description The number of post treatment controllers (PTC - i.e. patients under ART at baseline that show low peripheral blood proviral DNA and still will show sustained viral suppression at 48 weeks after treatment interruption) will be determined. The assessment will be based on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. Patients below the lower limit of detection (<50 HIV RNA copies/ml plasma) at 48 weeks after treatment interruption will be considered as PTC.
Time Frame 48 weeks after treatment interruption
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population contains all subjects enrolled in phase 2 (treatment interruption phase)
Arm/Group Title Treatment Interruption
Hide Arm/Group Description:

The ART treatment in patients with a very low viral reservoir will be interrupted.

ART interruption

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Number of Patients With and the Severity of Adverse Events That Are Related to the Study Intervention, Graded According to NCI CTCAE Version 4.0
Hide Description Confirmation of the safety of a treatment interruption strategy in selected patients will be based on the number and intensity of AEs graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death).
Time Frame 23 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed are the subject enrolled in het treatment interruption phase.
Arm/Group Title Treatment Interruption
Hide Arm/Group Description:

The ART treatment in patients with a very low viral reservoir will be interrupted.

ART interruption

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Fatigue Mild
1
   6.3%
Moderate
0
   0.0%
Severe
0
   0.0%
Life-threatening
0
   0.0%
No AE
15
  93.8%
Influenza-like illness Mild
1
   6.3%
Moderate
0
   0.0%
Severe
0
   0.0%
Life-threatening
0
   0.0%
No AE
15
  93.8%
Oropharyngeal pain Mild
1
   6.3%
Moderate
0
   0.0%
Severe
0
   0.0%
Life-threatening
0
   0.0%
No AE
15
  93.8%
3.Secondary Outcome
Title Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Total HIV DNA).
Hide Description Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of Total HIV DNA.
Time Frame At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed are the subjects enrolled in phase 2 (treatment interruption).
Arm/Group Title Phase 2 - Treatment Interruption
Hide Arm/Group Description:
The ART treatment in patients with a very low viral reservoir will be interrupted.
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: copies/10^6PBMCs
Screening
37.5
(11.5 to 55.5)
Baseline
22.5
(4.0 to 53.5)
Week 2
27.5
(11.0 to 69)
Week 4
46.5
(18 to 127)
Week 6
38.0
(22 to 141.5)
Week 8
83.5
(82 to 85)
Post week 12
42.5
(29 to 117)
4.Secondary Outcome
Title Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Unspliced RNA).
Hide Description Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of unspliced RNA.
Time Frame At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed are the subjects enrolled in phase 2 (treatment interruption).
Arm/Group Title Phase 2 - Treatment Interruption
Hide Arm/Group Description:
The ART treatment in patients with a very low viral reservoir will be interrupted.
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: copies/10^6PBMCs
Screening
2
(0.0 to 3.5)
Baseline
7.0
(4.0 to 16.5)
Week 2
7.5
(5.0 to 19.5)
Week 4
23.5
(5.0 to 179)
Week 6
30.5
(10.5 to 177)
Week 8
34.5
(31 to 38)
Post week 12
12
(5 to 15)
5.Secondary Outcome
Title Assessment of the Kinetics of HIV Viral Load Rebound After Treatment Interruption Based on the Repetitive Plasma Viral Load Measurements.
Hide Description The kinetics will be on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. A viral load of 19 means <20 copies/mL (lower limit of detection).
Time Frame At screening, baseline, week 2, week 4, week 6, week 8, End of Intervention (relapse), 4 weeks after relapse and 12 weeks after relapse
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed are the subjects enrolled in phase 2 (treatment interruption).
Arm/Group Title Phase 2 - Treatment Interruption
Hide Arm/Group Description:
The ART treatment in patients with a very low viral reservoir will be interrupted.
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: copies/mL
Screening
19
(19 to 19)
Baseline
19
(19 to 19)
Week 2
19
(19 to 55.5)
Week 4
1223
(26 to 40600)
Week 6
4020
(2110 to 21100)
Week 8
3480
(3480 to 3480)
En of Intervention (moment of relapse)
28000
(2330 to 44900)
Post week 4
22
(19 to 165)
Post week 12
19
(19 to 26)
Time Frame Adverse events were collected over the whole study period (from start of treatment interruption until end of follow-up period which was 12 weeks after relapse and treatment restart).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Interruption
Hide Arm/Group Description Subjects enrolled in phase 2 (treatment interruption). There was no AE collection during phase 1.
All-Cause Mortality
Treatment Interruption
Affected / at Risk (%)
Total   0/16 (0.00%)    
Hide Serious Adverse Events
Treatment Interruption
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Interruption
Affected / at Risk (%) # Events
Total   13/16 (81.25%)    
Gastrointestinal disorders   
Abdominal pain  1  1/16 (6.25%)  1
Faeces soft  1  1/16 (6.25%)  1
Stomatitis  1  1/16 (6.25%)  1
Vomiting  1  1/16 (6.25%)  1
General disorders   
Fatigue  1  3/16 (18.75%)  3
Influenza-like illness  1  4/16 (25.00%)  4
Infections and infestations   
Bronchitis  1  1/16 (6.25%)  1
Ear infection  1  1/16 (6.25%)  1
Fungal infection  1  1/16 (6.25%)  1
Influenza  1  1/16 (6.25%)  1
Nasopharyngitis  1  4/16 (25.00%)  4
Oral herpes  1  1/16 (6.25%)  1
Pyelonephritis  1  1/16 (6.25%)  1
Rhinitis  1  1/16 (6.25%)  1
Tracheitis  1  1/16 (6.25%)  1
Metabolism and nutrition disorders   
Vit D deficiency  1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/16 (6.25%)  1
Back pain  1  1/16 (6.25%)  1
Fasciitis  1  1/16 (6.25%)  1
Psychiatric disorders   
Insomnia  1  1/16 (6.25%)  1
Renal and urinary disorders   
Dysuria  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/16 (12.50%)  2
Oropharyngeal pain  1  1/16 (6.25%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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. Eric Florence
Organization: Institute of Tropical Medicine Antwerp
Phone: +32 3 247 66 42
EMail: eflorence@itg.be
Layout table for additonal information
Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02590354    
Other Study ID Numbers: ITM0714
First Submitted: October 14, 2015
First Posted: October 29, 2015
Results First Submitted: August 5, 2019
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019