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Trial record 1 of 1 for:    NCT00791700
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An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children

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ClinicalTrials.gov Identifier: NCT00791700
Recruitment Status : Active, not recruiting
First Posted : November 14, 2008
Results First Posted : February 25, 2016
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus
Intervention Drug: Maraviroc
Enrollment 103
Recruitment Details This open-label, multicenter, multiple dose pharmacokinetic, safety and efficacy study at 24 sites in 8 countries.
Pre-assignment Details The participants were HIV-1 infected treatment-experienced children and adolescents who were failing current antiretroviral (ARV) therapy or have failed their most recent ARV regimen, defined by plasma HIV-1 RNA>=1000 copies/mL, were infected with only R5 HIV-1, and have ARV experience/intolerance of 6 months with at least 2 ARV drug classes.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 milligram per milliliter [mg/mL]). In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 milligram [mg], 75 mg, 150 mg). In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Period Title: Overall Study
Started 16 31 13 43
Completed 10 20 7 13
Not Completed 6 11 6 30
Reason Not Completed
Insufficient clinical response             1             4             1             8
No longer willing to participate             1             1             0             8
Non-compliance with study treatment             0             2             0             4
Withdrawn due to pregnancy             0             0             0             1
Other             0             1             0             1
Death             0             0             0             1
Lost to Follow-up             4             3             4             6
Adverse Event             0             0             1             1
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation Total
Hide Arm/Group Description In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). Total of all reporting groups
Overall Number of Baseline Participants 16 31 13 43 103
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) consisted of all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 31 participants 13 participants 43 participants 103 participants
3.4  (0.9) 9.1  (1.7) 8.9  (2.0) 14.0  (1.6) 10.3  (4.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 31 participants 13 participants 43 participants 103 participants
Female
5
  31.3%
16
  51.6%
6
  46.2%
27
  62.8%
54
  52.4%
Male
11
  68.8%
15
  48.4%
7
  53.8%
16
  37.2%
49
  47.6%
1.Primary Outcome
Title Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax)
Hide Description Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.
Time Frame Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed": participants evaluable at specified time points for this measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 12 11 10 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
Cavg-Week2 Number Analyzed 12 participants 11 participants 10 participants 17 participants
237.34
(63%)
260.65
(43%)
264.45
(62%)
239.85
(67%)
Cavg-Week 48 Number Analyzed 9 participants 8 participants 8 participants 12 participants
163.73
(146%)
289.69
(50%)
168.62
(117%)
199.12
(78%)
Cmax-Week2 Number Analyzed 12 participants 11 participants 10 participants 17 participants
581.47
(69%)
546.80
(51%)
444.37
(61%)
530.80
(62%)
Cmax-Week 48 Number Analyzed 9 participants 8 participants 8 participants 12 participants
334.68
(156%)
593.68
(25%)
284.96
(128%)
423.32
(48%)
Cmin-Week2 Number Analyzed 12 participants 11 participants 10 participants 17 participants
18.97
(202208%)
100.02
(39%)
115.84
(90%)
56.17
(145%)
Cmin-Week 48 Number Analyzed 9 participants 8 participants 8 participants 12 participants
48.11
(180%)
82.21
(120%)
60.03
(245%)
66.51
(140%)
2.Primary Outcome
Title Area Under the Curve at Steady State (AUCtau)
Hide Description AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.
Time Frame Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed" signifies participants evaluable at specified time points for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 12 11 10 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
AUCtau - Week 2 Number Analyzed 12 participants 11 participants 10 participants 17 participants
2848.1
(63%)
3127.7
(43%)
3173.4
(62%)
2878.2
(67%)
AUCtau - Week 48 Number Analyzed 9 participants 8 participants 8 participants 12 participants
1964.7
(146%)
3476.3
(50%)
2023.5
(117%)
2389.4
(78%)
3.Primary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed" signifies participants evaluable at specified time points for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 12 11 10 17
Median (Full Range)
Unit of Measure: hour
Tmax - Week 2 Number Analyzed 12 participants 11 participants 10 participants 17 participants
2.000
(0.97 to 6.00)
4.000
(0.75 to 6.00)
2.000
(1.00 to 4.00)
2.000
(1.00 to 4.00)
Tmax - Week 48 Number Analyzed 9 participants 8 participants 8 participants 12 participants
2.000
(0.00 to 6.03)
2.000
(1.00 to 8.00)
3.000
(0.00 to 6.00)
2.000
(1.00 to 4.00)
4.Primary Outcome
Title Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)
Hide Description Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term.
Time Frame Baseline up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was performed on all participants who received at least 1 dose of study drug.
Arm/Group Title Cohort 1 (Grade 3) Cohort 1 (Grade 4) Cohort 2 (Grade 3) Cohort 2 (Grade 4) Cohort 3 (Grade 3) Cohort 3 (Grade 4) Cohort 4 (Grade 3) Cohort 4 (Grade 4)
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 16 16 31 31 13 13 43 43
Measure Type: Number
Unit of Measure: events
Gastrointestinal disorders - Vomiting 1 0 1 0 0 0 0 0
Hepat. disorders - Drug-induced liver injury 0 0 0 0 0 0 0 1
Infections and infestations - H1N1 influenza 0 0 0 0 0 0 1 0
Infections and infestations - Pneumonia 0 0 0 0 1 0 1 0
Investigations - Lipase increased 0 1 0 0 0 0 0 0
Pyschiatric disorder - Bipolar disorder 0 0 1 0 0 0 0 0
Gastrointestinal disorders - Gastritis 0 0 1 0 0 0 0 0
Investigations - Hepatic enzyme abnormal 0 0 1 0 0 0 0 0
Investigations - Transaminases increased 0 0 1 0 0 0 0 0
Pyschiatric disorder - Aggression 0 0 1 0 0 0 0 0
Blood and lymphatic system disorders - Anaemia 0 0 0 0 0 0 1 0
Infections and infestations - Meningitis 0 0 0 0 0 0 0 1
Infections and infestations -Otitis media 0 0 1 0 0 0 0 0
5.Primary Outcome
Title Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug
Hide Description The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.
Time Frame Baseline up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was performed on all participants who received at least 1 dose of study drug.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 16 31 13 43
Measure Type: Number
Unit of Measure: participants
0 0 0 0
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach
Hide Description The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
Time Frame Week 24 and Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who receive at least one dose of study medication.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 16 31 13 43
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 68.8 90.3 69.2 62.8
Week 48 75.0 77.4 69.2 51.2
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach
Hide Description The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
Time Frame Week 24 and Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 16 31 13 43
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 18.75 64.5 61.5 48.8
Week 48 50.0 54.8 53.8 39.5
8.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach
Hide Description Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].
Time Frame Week 24 and Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this measure."Number analyzed" signifies participants evaluable at specified time points for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 12 27 9 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 24 Number Analyzed 10 participants 27 participants 9 participants 27 participants
62.5
(38.8 to 86.2)
87.10
(75.3 to 98.9)
69.2
(44.1 to 94.3)
62.8
(48.3 to 77.2)
Week 48 Number Analyzed 12 participants 23 participants 9 participants 22 participants
75.0
(53.8 to 96.2)
74.2
(58.8 to 89.6)
69.2
(44.1 to 94.3)
51.2
(36.2 to 66.1)
9.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach
Hide Description Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].
Time Frame Week 24 and Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this measure."Number analyzed" signifies participants evaluable at specified time points for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 8 20 8 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 24 Number Analyzed 3 participants 20 participants 8 participants 21 participants
18.8
(0.0 to 37.9)
64.5
(47.7 to 81.4)
61.5
(35.1 to 89.0)
48.8
(33.9 to 63.8)
Week 48 Number Analyzed 8 participants 16 participants 8 participants 17 participants
50.0
(25.5 to 74.5)
54.8
(34.0 to 69.2)
53.8
(35.1 to 89.0)
39.5
(24.9 to 54.2)
10.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48
Hide Description TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 16 31 13 43
Measure Type: Number
Unit of Measure: Percentage of participants
<400 copies/mL; TLOVR Responder 62.5 74.2 69.2 48.8
<48 copies/mL; TLOVR Responder 43.8 54.8 46.2 44.2
11.Secondary Outcome
Title Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48
Hide Description Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.
Time Frame Baseline to Week 24, Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. Last Observation Carried Forward (LOCF) was used to impute missing values.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 16 31 13 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline to Week 24
92.3
(77.8 to 106.8)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
93.1
(83.9 to 102.3)
Baseline to Week 48
100.0
(100.0 to 100.0)
96.2
(88.8 to 103.6)
100.0
(100.0 to 100.0)
88.0
(75.3 to 100.7)
12.Secondary Outcome
Title Change From Baseline in HIV-1 RNA (Original)
Hide Description Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.
Time Frame Baseline, Week 24, Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 15 31 12 39
Mean (Standard Deviation)
Unit of Measure: copies/mL
Change from Baseline - Original - Week 24 -271974.6  (391843.59) -38764.0  (63688.93) -58081.0  (79720.33) -57325.7  (172108.62)
Change from Baseline - Original - Week 48 -267834.2  (378896.88) -34787.7  (60222.60) -56351.7  (76231.03) -55321.1  (173840.55)
13.Secondary Outcome
Title Change From Baseline in HIV-1 RNA (Log10 Copies/mL)
Hide Description Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.
Time Frame Baseline, Week 24, Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 15 31 12 39
Mean (Standard Deviation)
Unit of Measure: Log10 Copies/mL
Change from Baseline - Log10 - Week 24 -2.4853  (1.1421) -2.2324  (0.8668) -2.1756  (1.1854) -1.6482  (1.3806)
Change from Baseline - Log10 - Week 48 -2.5831  (1.2148) -1.9579  (1.0861) -2.0549  (1.2125) -1.4591  (1.4477)
14.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48
Hide Description Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.
Time Frame Baseline, Week 24, Week 48 post-treatment
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Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 15 30 12 39
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Week 24 232.7  (381.6) 355.8  (294.0) 213.9  (166.4) 173.6  (203.6)
Week 48 275.9  (363.4) 362.7  (373.5) 167.3  (150.9) 168.6  (211.0)
15.Secondary Outcome
Title Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48
Hide Description Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.
Time Frame Baseline, Week 24 and Week 48 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 15 31 12 39
Mean (Standard Deviation)
Unit of Measure: percentage of CD4+ cells
Week 24 7.3  (5.0) 3.8  (7.4) 3.5  (4.0) 3.8  (6.1)
Week 48 7.5  (7.6) 6.0  (6.8) 2.5  (4.2) 4.6  (6.5)
16.Secondary Outcome
Title Number of Participants With Protocol Defined Virologic Failure
Hide Description The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days.
Time Frame Week 48
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Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 16 31 13 43
Measure Type: Number
Unit of Measure: participants
Criteria A 0 2 1 5
Criteria B 0 0 0 0
Criteria C 3 3 2 8
17.Secondary Outcome
Title Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48
Hide Description Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.
Time Frame Screening to Week 48
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Hide Analysis Population Description
Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 3 4 3 13
Measure Type: Number
Unit of Measure: participants
With valid on-treatment results 2 4 3 11
Tropism at Confirmed PDVF R5 2 3 2 9
Tropism at Confirmed PDVF DM 0 1 1 2
Tropism at Confirmed PDVF X4 0 0 0 0
Tropism at Confirmed PDVF Not Reportable 1 0 0 1
18.Secondary Outcome
Title Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF
Hide Description Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description:
In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL).
In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL).
In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
Overall Number of Participants Analyzed 3 4 3 13
Measure Type: Number
Unit of Measure: participants
With valid on-treatment results 2 4 3 11
PI Minor L10L/F 0 0 0 1
PI Minor L89L/I/M 0 0 0 1
PI Minor V77V/I 0 0 0 1
NNRTI K103K/N 0 1 0 0
NNRTI K103N 0 0 1 1
NRTI M184V 0 0 1 0
PI Minor K20K/R 0 0 2 0
Total with emergence 0 1 3 4
19.Secondary Outcome
Title Percentage of Participants With Optimized Background Treatment Susceptibility Scores
Hide Description Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, >=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and >=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants who received at least 1 dose of study drug.
Arm/Group Title Response PDVF Other Failure/Remainder
Hide Arm/Group Description:
Participants with plasma HIV-1 RNA <48 copies/mL
Participants who meet the protocol-defined virologic failure
Participants with other failures
Overall Number of Participants Analyzed 49 23 31
Measure Type: Number
Unit of Measure: Percentage of participants
Simple score 0 0 0 0
Simple score 1.0 8.2 4.3 0
Simple score >=2.0 81.6 95.7 96.8
Weighted score 0-0.5 6.1 30.4 29.0
Weighted score 1.0-1.5 53.1 65.2 29.0
Weighted score >=2.0 28.6 4.3 38.7
Time Frame Baseline up to 5 years
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title >=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Hide Arm/Group Description In Cohort 1, Participants aged >= 2 to < 6 years, received MVC liquid formulation (20 mg/mL). In Cohort 2, Participants aged >=6 to <12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). In Cohort 3, Participants aged >=6 to <12 years, received MVC liquid formulation (20 mg/mL). In Cohort 4, Participants aged >=12 to <18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).
All-Cause Mortality
>=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/31 (0.00%)   0/13 (0.00%)   1/43 (2.33%) 
Hide Serious Adverse Events
>=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/16 (31.25%)   5/31 (16.13%)   3/13 (23.08%)   10/43 (23.26%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Ear and labyrinth disorders         
Otorrhoea * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Gastrointestinal disorders         
Gastric fistula * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Gastritis * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Vomiting * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Constipation * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Diarrhoea * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Hepatobiliary disorders         
Drug-induced liver injury * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Infections and infestations         
Abscess oral * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Cellulitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
H1N1 influenza * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Pelvic inflammatory disease * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Pneumonia * 1  0/16 (0.00%)  1/31 (3.23%)  1/13 (7.69%)  2/43 (4.65%) 
Pulmonary tuberculosis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Tooth abscess * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Viral infection * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Gastroenteritis * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Meningitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Investigations         
Transaminases increased * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteopenia * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Pain in extremity * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Tendon disorder * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Psychiatric disorders         
Bipolar disorder * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Hyperventilation * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Skin and subcutaneous tissue disorders         
Prurigo * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
1
Term from vocabulary, MedDRA (v18.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
>=2 - <6 Years of Age, MVC Liquid Formulation >=6 - <12 Years of Age, MVC Tablet Formulation >=6 - <12 Years of Age, MVC Liquid Formulation >=12 - <18 Years of Age, MVC Tablet Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/16 (75.00%)   25/31 (80.65%)   10/13 (76.92%)   34/43 (79.07%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  3/43 (6.98%) 
Iron deficiency anaemia * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Lymphadenitis * 1  1/16 (6.25%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Lymphadenopathy * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  5/43 (11.63%) 
Neutropenia * 1  2/16 (12.50%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Cardiac disorders         
Cardiac disorder * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Ear and labyrinth disorders         
Deafness * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Cerumen impaction * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Ear haemorrhage * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Eye disorders         
Conjunctival pallor * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Conjunctivitis allergic * 1  1/16 (6.25%)  2/31 (6.45%)  0/13 (0.00%)  1/43 (2.33%) 
Hypermetropia * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Refraction disorder * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Abdominal pain * 1  0/16 (0.00%)  1/31 (3.23%)  2/13 (15.38%)  4/43 (9.30%) 
Abdominal pain lower * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Abdominal pain upper * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Anal pruritus * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Constipation * 1  2/16 (12.50%)  1/31 (3.23%)  0/13 (0.00%)  2/43 (4.65%) 
Dental caries * 1  0/16 (0.00%)  1/31 (3.23%)  1/13 (7.69%)  1/43 (2.33%) 
Diarrhoea * 1  7/16 (43.75%)  3/31 (9.68%)  4/13 (30.77%)  9/43 (20.93%) 
Dyspepsia * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Flatulence * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Gingival swelling * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Mouth ulceration * 1  1/16 (6.25%)  0/31 (0.00%)  1/13 (7.69%)  1/43 (2.33%) 
Nausea * 1  0/16 (0.00%)  3/31 (9.68%)  0/13 (0.00%)  5/43 (11.63%) 
Odynophagia * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Proctitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Salivary gland mucocoele * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Tongue disorder * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Toothache * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Vomiting * 1  6/16 (37.50%)  8/31 (25.81%)  3/13 (23.08%)  4/43 (9.30%) 
General disorders         
Asthenia * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Fatigue * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Influenza like illness * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Malaise * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Pyrexia * 1  2/16 (12.50%)  1/31 (3.23%)  2/13 (15.38%)  5/43 (11.63%) 
Hepatobiliary disorders         
Hepatotoxicity * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Hyperbilirubinaemia * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Immune system disorders         
Allergy to arthropod bite * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Infections and infestations         
Abscess * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Acarodermatitis * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Bacterial vaginosis * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Bronchitis * 1  3/16 (18.75%)  3/31 (9.68%)  0/13 (0.00%)  7/43 (16.28%) 
Bullous impetigo * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Conjunctivitis * 1  2/16 (12.50%)  2/31 (6.45%)  0/13 (0.00%)  1/43 (2.33%) 
Cystitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Ear infection * 1  1/16 (6.25%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Fungal skin infection * 1  1/16 (6.25%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Gastroenteritis * 1  3/16 (18.75%)  0/31 (0.00%)  2/13 (15.38%)  2/43 (4.65%) 
Gastroenteritis viral * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Gingivitis * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Herpes virus infection * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Hordeolum * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Impetigo * 1  1/16 (6.25%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Influenza * 1  2/16 (12.50%)  6/31 (19.35%)  3/13 (23.08%)  5/43 (11.63%) 
Latent tuberculosis * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Lice infestation * 1  0/16 (0.00%)  2/31 (6.45%)  0/13 (0.00%)  1/43 (2.33%) 
Nasopharyngitis * 1  4/16 (25.00%)  4/31 (12.90%)  0/13 (0.00%)  3/43 (6.98%) 
Oral herpes * 1  1/16 (6.25%)  2/31 (6.45%)  0/13 (0.00%)  1/43 (2.33%) 
Otitis externa * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Otitis media * 1  6/16 (37.50%)  1/31 (3.23%)  1/13 (7.69%)  0/43 (0.00%) 
Otitis media acute * 1  2/16 (12.50%)  2/31 (6.45%)  0/13 (0.00%)  0/43 (0.00%) 
Otitis media chronic * 1  2/16 (12.50%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Paronychia * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Parotitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Pharyngitis * 1  1/16 (6.25%)  1/31 (3.23%)  0/13 (0.00%)  2/43 (4.65%) 
Oropharyngeal candidiasis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Pharyngotonsillitis * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Pneumonia * 1  0/16 (0.00%)  3/31 (9.68%)  0/13 (0.00%)  2/43 (4.65%) 
Pneumonia bacterial * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Rhinitis * 1  3/16 (18.75%)  1/31 (3.23%)  0/13 (0.00%)  3/43 (6.98%) 
Sinobronchitis * 1  0/16 (0.00%)  2/31 (6.45%)  0/13 (0.00%)  0/43 (0.00%) 
Sinusitis * 1  1/16 (6.25%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Tinea capitis * 1  2/16 (12.50%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Tinea faciei * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Tinea infection * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Tonsillitis * 1  1/16 (6.25%)  2/31 (6.45%)  0/13 (0.00%)  2/43 (4.65%) 
Tooth abscess * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Tracheitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Tuberculosis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Upper respiratory tract infection * 1  7/16 (43.75%)  6/31 (19.35%)  2/13 (15.38%)  5/43 (11.63%) 
Varicella * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Viral infection * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Viral upper respiratory tract infection * 1  3/16 (18.75%)  2/31 (6.45%)  3/13 (23.08%)  1/43 (2.33%) 
Vulvovaginitis * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Wound infection * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Conjunctivitis bacterial * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Mastoiditis * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Viral rash * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Fungal infection * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Pulmonary tuberculosis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Urinary tract infection * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Angular cheilitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Injury, poisoning and procedural complications         
Accidental exposure to product * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Arthropod bite * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Arthropod sting * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Contusion * 1  0/16 (0.00%)  2/31 (6.45%)  0/13 (0.00%)  0/43 (0.00%) 
Fall * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Foot fracture * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Head injury * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Injury * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Ligament sprain * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Limb injury * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Muscle strain * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Overdose * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Skin abrasion * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  2/43 (4.65%) 
Thermal burn * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Underdose * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Accidental overdose * 1  1/16 (6.25%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Ankle fracture * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Traumatic ulcer * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Traumatic haematoma * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Investigations         
Blood HIV RNA increased * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Blood alkaline phosphatase increased * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Blood creatine phosphokinase increased * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Blood iron decreased * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Blood phosphorus decreased * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Cardiac murmur * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Hepatic enzyme abnormal * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Hepatic enzyme increased * 1  1/16 (6.25%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Lipase increased * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Neutrophil count decreased * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Viral load increased * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Weight decreased * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Weight increased * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Haemoglobin decreased * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Dehydration * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Hyperglycaemia * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Hypertriglyceridaemia * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Hypokalaemia * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Insulin resistance * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Vitamin D deficiency * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/16 (0.00%)  2/31 (6.45%)  0/13 (0.00%)  2/43 (4.65%) 
Back pain * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Bone swelling * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Bursitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Joint swelling * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Musculoskeletal discomfort * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Myofascial pain syndrome * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Osteoporosis * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Pain in extremity * 1  0/16 (0.00%)  1/31 (3.23%)  1/13 (7.69%)  1/43 (2.33%) 
Musculoskeletal stiffness * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Myalgia * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Nervous system disorders         
Dizziness * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  3/43 (6.98%) 
Epilepsy * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Generalised tonic-clonic seizure * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Headache * 1  0/16 (0.00%)  2/31 (6.45%)  2/13 (15.38%)  6/43 (13.95%) 
Lethargy * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Somnolence * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Tension headache * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Intellectual disability * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Pregnancy * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Psychiatric disorders         
Attention deficit/hyperactivity disorder * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Depression * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Hallucination * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Insomnia * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Nightmare * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  0/43 (0.00%) 
Panic disorder * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Aggression * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Flat affect * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Reproductive system and breast disorders         
Amenorrhoea * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Breast enlargement * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Breast mass * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Breast pain * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Dysmenorrhoea * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Bronchospasm * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Catarrh * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Cough * 1  1/16 (6.25%)  6/31 (19.35%)  2/13 (15.38%)  3/43 (6.98%) 
Epistaxis * 1  1/16 (6.25%)  2/31 (6.45%)  0/13 (0.00%)  0/43 (0.00%) 
Hyperventilation * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Nasal congestion * 1  0/16 (0.00%)  1/31 (3.23%)  1/13 (7.69%)  1/43 (2.33%) 
Oropharyngeal pain * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Pharyngeal disorder * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Productive cough * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  1/43 (2.33%) 
Respiratory disorder * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Rhinitis allergic * 1  0/16 (0.00%)  2/31 (6.45%)  0/13 (0.00%)  1/43 (2.33%) 
Rhinorrhoea * 1  0/16 (0.00%)  2/31 (6.45%)  1/13 (7.69%)  2/43 (4.65%) 
Rhonchi * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Bronchial hyperreactivity * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Allergic cough * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Skin and subcutaneous tissue disorders         
Acanthosis nigricans * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Acne * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Dermatitis * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  2/43 (4.65%) 
Dermatitis allergic * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Dermatitis contact * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Dermatitis diaper * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Dry skin * 1  0/16 (0.00%)  0/31 (0.00%)  2/13 (15.38%)  1/43 (2.33%) 
Ecchymosis * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Eczema * 1  0/16 (0.00%)  0/31 (0.00%)  1/13 (7.69%)  1/43 (2.33%) 
Papule * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Prurigo * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Rash * 1  3/16 (18.75%)  1/31 (3.23%)  1/13 (7.69%)  1/43 (2.33%) 
Rash pruritic * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  1/43 (2.33%) 
Skin lesion * 1  0/16 (0.00%)  0/31 (0.00%)  2/13 (15.38%)  0/43 (0.00%) 
Urticaria * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Urticaria papular * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Lipodystrophy acquired * 1  0/16 (0.00%)  1/31 (3.23%)  0/13 (0.00%)  0/43 (0.00%) 
Neurodermatitis * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
Surgical and medical procedures         
Tooth extraction * 1  1/16 (6.25%)  0/31 (0.00%)  0/13 (0.00%)  0/43 (0.00%) 
Vascular disorders         
Hypertension * 1  0/16 (0.00%)  0/31 (0.00%)  0/13 (0.00%)  1/43 (2.33%) 
1
Term from vocabulary, MedDRA (v18.0)
*
Indicates events were collected by non-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.
Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00791700    
Other Study ID Numbers: A4001031
2008-006873-33 ( EudraCT Number )
First Submitted: November 12, 2008
First Posted: November 14, 2008
Results First Submitted: October 6, 2015
Results First Posted: February 25, 2016
Last Update Posted: April 28, 2020