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T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

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ClinicalTrials.gov Identifier: NCT00022763
Recruitment Status : Completed
First Posted : August 31, 2001
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Enfuvirtide
Enrollment 52
Recruitment Details Overall, 52 participants were enrolled in this study conducted at 16 centers in Spain and United States between 23 August 2001 and 09 December 2004.
Pre-assignment Details  
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first. Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Period Title: Overall Study
Started 24 28
Completed 15 11
Not Completed 9 17
Reason Not Completed
Adverse Event             1             2
Injection Site Reactions             0             2
Death             0             1
Lost to Follow-up             0             3
Withdrawal by Subject             4             7
Insufficient Therapy             1             0
Admin             3             2
Arm/Group Title Stratum A Stratum B Total
Hide Arm/Group Description Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first. Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first. Total of all reporting groups
Overall Number of Baseline Participants 24 28 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 28 participants 52 participants
8.7  (1.8) 13.9  (1.6) 11.5  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 28 participants 52 participants
Female
15
  62.5%
9
  32.1%
24
  46.2%
Male
9
  37.5%
19
  67.9%
28
  53.8%
1.Primary Outcome
Title Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)
Hide Description The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
Time Frame Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: microgram hour per milliliter (mcg.h/mL)
Enfuvirtide 56.1  (19.4) 52.7  (27.4)
Metabolite (Ro 50-6343) 3.07  (2.77) 3.41  (2.09)
2.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Hide Description The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
Time Frame Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Enfuvirtide 6.43  (2.15) 5.88  (2.81)
Metabolite (Ro 50-6343) 0.434  (0.667) 0.450  (0.341)
3.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide
Hide Description Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time Frame Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: hour
4.13  (1.35) 5.05  (2.67)
4.Secondary Outcome
Title Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Hide Description Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.
Time Frame Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Enfuvirtide 2.87  (1.49) 2.98  (1.66)
Metabolite (Ro 50-6343) 0.177  (0.089) 0.242  (0.146)
5.Secondary Outcome
Title AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)
Hide Description The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated.
Time Frame Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: Ratio
5.31  (3.55) 7.12  (3.98)
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious AEs
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.
Time Frame Up to Week 4 after discontinuation of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population: All participants who received at least one dose of study medication were included.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 24 28
Measure Type: Number
Unit of Measure: participants
Any AE 24 25
Any SAE 8 15
7.Secondary Outcome
Title Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities
Hide Description Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population: All participants who received at least one dose of study medication were included.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 24 26
Measure Type: Number
Unit of Measure: participants
Platelets Grade 3 0 2
Platelets Grade 4 1 0
Neutrophils Grade 3 0 0
Neutrophils Grade 4 1 0
ASAT Grade 3 2 0
ASAT Grade 4 0 0
ALAT Grade 3 1 0
ALAT Grade 4 0 0
Total Bilirubin Grade 3 0 1
Total Bilirubin Grade 4 0 0
GGT Grade 3 0 1
GGT Grade 4 0 0
Amylase Grade 3 1 1
Amylase Grade 4 1 1
8.Secondary Outcome
Title Number of Participants Who Died
Hide Description [Not Specified]
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population: All participants who received at least one dose of study medication were included.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 24 28
Measure Type: Number
Unit of Measure: participants
1 1
9.Secondary Outcome
Title Number of Participants Who Prematurely Withdrew Due to AE
Hide Description [Not Specified]
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population: All participants who received at least one dose of study medication were included.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 24 28
Measure Type: Number
Unit of Measure: participants
9 17
10.Secondary Outcome
Title Number of Participants With Worst Local Injection Site Reactions
Hide Description Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population: All participants who received at least one dose of study medication were included.
Arm/Group Title Stratum A Stratum B
Hide Arm/Group Description:
Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Overall Number of Participants Analyzed 24 28
Measure Type: Number
Unit of Measure: participants
Erythema 13 19
Nodules and Cysts 16 14
Induration 21 20
Pruritus 10 9
Ecchymosis 6 8
Others 5 10
Time Frame Up to Week 96
Adverse Event Reporting Description All participants who received at least one dose of study medication were included in safety analysis.
 
Arm/Group Title Enfuvirtide
Hide Arm/Group Description Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).
All-Cause Mortality
Enfuvirtide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enfuvirtide
Affected / at Risk (%)
Total   31/52 (59.62%) 
Blood and lymphatic system disorders   
Neutropenia † 1  1/52 (1.92%) 
General disorders   
Pyrexia † 1  2/52 (3.85%) 
Injection site abscess † 1  1/52 (1.92%) 
Multi-organ failure † 1  1/52 (1.92%) 
Infections and infestations   
Pneumonia nos † 1  4/52 (7.69%) 
Cellulitis † 1  3/52 (5.77%) 
Gastroenteritis nos † 1  2/52 (3.85%) 
Bronchiolitis † 1  1/52 (1.92%) 
Bronchitis nos † 1  1/52 (1.92%) 
Colitis pseudomembranous † 1  1/52 (1.92%) 
Gastroenteritis viral nos † 1  1/52 (1.92%) 
Kawasaki's disease † 1  1/52 (1.92%) 
Lobar pneumonia nos † 1  1/52 (1.92%) 
Pneumonia viral nos † 1  1/52 (1.92%) 
Septic shock † 1  1/52 (1.92%) 
Sinusitis nos † 1  1/52 (1.92%) 
Staphylococcal abscess † 1  1/52 (1.92%) 
Investigations   
Blood creatinine increased † 1  1/52 (1.92%) 
Blood urea increased † 1  1/52 (1.92%) 
Metabolism and nutrition disorders   
Metabolic disorder nos † 1  1/52 (1.92%) 
Tetany † 1  1/52 (1.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Sweat gland tumour † 1  1/52 (1.92%) 
Nervous system disorders   
Dystonia † 1  1/52 (1.92%) 
Skin and subcutaneous tissue disorders   
Rash papular † 1  1/52 (1.92%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enfuvirtide
Affected / at Risk (%)
Total   52/52 (100.00%) 
Blood and lymphatic system disorders   
Lymphadenopathy † 1  7/52 (13.46%) 
Ear and labyrinth disorders   
Earache † 1  3/52 (5.77%) 
Eye disorders   
Conjunctivitis nec † 1  5/52 (9.62%) 
Conjunctivitis allergic † 1  4/52 (7.69%) 
Vision blurred † 1  3/52 (5.77%) 
Gastrointestinal disorders   
Nausea † 1  11/52 (21.15%) 
Vomiting nos † 1  11/52 (21.15%) 
Diarrhoea nos † 1  9/52 (17.31%) 
Abdominal pain nos † 1  7/52 (13.46%) 
Abdominal pain upper † 1  6/52 (11.54%) 
Loose stools † 1  5/52 (9.62%) 
Sore throat nos † 1  4/52 (7.69%) 
Mouth ulceration † 1  3/52 (5.77%) 
General disorders   
Pyrexia † 1  11/52 (21.15%) 
Fatigue † 1  6/52 (11.54%) 
Immune system disorders   
Hypersensitivity Nos † 1  4/52 (7.69%) 
Infections and infestations   
Upper respiratory tract infection nos † 1  22/52 (42.31%) 
Otitis media nos † 1  12/52 (23.08%) 
Nasopharyngitis † 1  9/52 (17.31%) 
Sinusitis nos † 1  8/52 (15.38%) 
Oral candidiasis † 1  6/52 (11.54%) 
Body tinea † 1  4/52 (7.69%) 
Impetigo nos † 1  4/52 (7.69%) 
Viral infection nos † 1  4/52 (7.69%) 
Gastroenteritis nos † 1  3/52 (5.77%) 
Herpes simplex † 1  3/52 (5.77%) 
Herpes zoster † 1  4/52 (7.69%) 
Injury, poisoning and procedural complications   
Arthropod bite † 1  3/52 (5.77%) 
Investigations   
Weight decreased † 1  5/52 (9.62%) 
Haematuria present † 1  3/52 (5.77%) 
Metabolism and nutrition disorders   
Appetite decreased nos † 1  3/52 (5.77%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  3/52 (5.77%) 
Back Pain † 1  3/52 (5.77%) 
Nervous system disorders   
Headache Nos † 1  6/52 (11.54%) 
Renal and urinary disorders   
Dysuria † 1  3/52 (5.77%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  13/52 (25.00%) 
Bronchospasm nos † 1  6/52 (11.54%) 
Nasal congestion † 1  6/52 (11.54%) 
Rhinitis allergic nos † 1  4/52 (7.69%) 
Rhinorrhoea † 1  4/52 (7.69%) 
Asthma nos † 1  3/52 (5.77%) 
Wheezing † 1  3/52 (5.77%) 
Skin and subcutaneous tissue disorders   
Dermatitis Nos † 1  10/52 (19.23%) 
Acne Nos † 1  5/52 (9.62%) 
Eczema Seborrhoeic † 1  3/52 (5.77%) 
Rash papular † 1  3/52 (5.77%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
[Not Specified]
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00022763     History of Changes
Other Study ID Numbers: NV16056
T20-310
295E
First Submitted: August 11, 2001
First Posted: August 31, 2001
Results First Submitted: December 4, 2015
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016