Trial Outcomes & Findings for Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé) (NCT NCT00928187)
NCT ID: NCT00928187
Last Updated: 2017-02-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
454 participants
Primary outcome timeframe
48 weeks
Results posted on
2017-02-27
Participant Flow
Recruitment in three study sites (Yaoundé, Dakar and Bobo Dioulasso) in HIV day care clinics from January 2010 to September 2012.
584 patients assessed for eligibility, 130 excluded primary (13.9%) because control viral load decreased below 1000 copies/mL after adherence support.
Participant milestones
| Measure |
Arm A
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Overall Study
STARTED
|
152
|
147
|
155
|
|
Overall Study
Analysed
|
152
|
145
|
154
|
|
Overall Study
COMPLETED
|
150
|
141
|
150
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
5
|
Reasons for withdrawal
| Measure |
Arm A
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé)
Baseline characteristics by cohort
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38 years
n=5 Participants
|
38 years
n=7 Participants
|
36 years
n=5 Participants
|
38 years
n=4 Participants
|
|
Gender
Female
|
113 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
|
Gender
Male
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Region of Enrollment
Cameroon
|
101 participants
n=5 Participants
|
99 participants
n=7 Participants
|
102 participants
n=5 Participants
|
302 participants
n=4 Participants
|
|
Region of Enrollment
Burkina Faso
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
32 participants
n=5 Participants
|
90 participants
n=4 Participants
|
|
Region of Enrollment
Senegal
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
20 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
HIV RNA Viral Load
|
4.4 log10 (copies/ml)
n=5 Participants
|
4.6 log10 (copies/ml)
n=7 Participants
|
4.5 log10 (copies/ml)
n=5 Participants
|
4.5 log10 (copies/ml)
n=4 Participants
|
|
Resistance to the three first-line drugs
|
84 participants
n=5 Participants
|
77 participants
n=7 Participants
|
88 participants
n=5 Participants
|
249 participants
n=4 Participants
|
|
CD4 cells count
|
199 cells/mm3
n=5 Participants
|
195 cells/mm3
n=7 Participants
|
153 cells/mm3
n=5 Participants
|
183 cells/mm3
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: ITT
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Number of Patients With Plasma HIV RNA < 50 Copies/mL
|
105 participants
|
92 participants
|
97 participants
|
SECONDARY outcome
Timeframe: between baseline and 48 weeksPopulation: ITT
patients having a diagnosis of HIV related event classified as stage 3 or 4
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Number of Patients With WHO Stage 3 and 4 HIV Related Events
|
17 participants
|
23 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: ITT
number of patients with plasma HIV RNA below 200 copies/ml
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Patients With Plasma HIV RNA < 200 Copies/ml
|
130 participants
|
118 participants
|
127 participants
|
SECONDARY outcome
Timeframe: between baseline and 48 weeksPopulation: ITT with data available
median gain in circulating CD4 cells between baseline and W48
Outcome measures
| Measure |
Arm A
n=150 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=140 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=149 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Gain in CD4 Cells Between Baseline and W48
|
133 cell/mm3
Interval 82.0 to 220.0
|
136 cell/mm3
Interval 78.0 to 206.0
|
115 cell/mm3
Interval 58.0 to 187.0
|
SECONDARY outcome
Timeframe: between baseline and W48Population: ITT
number of patients discounting treatment because of adverse events
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Number of Patients Discontinuing Study Treatment
|
0 participants
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: between baseline and 48 weeksPopulation: ITT
Gastrointestinal complaints (grade 1 to 4) between baseline and W48.
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Tolerance: Gastrointestinal Complains
|
50 participants
|
48 participants
|
26 participants
|
SECONDARY outcome
Timeframe: between baseline and W48Population: ITT
any symptom of peripheral neuropathy
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Tolerance: Neuropathies (Grade 1 to 4)
|
5 participants
|
11 participants
|
8 participants
|
SECONDARY outcome
Timeframe: between baseline and W48Population: ITT
evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
|
28 participants
|
14 participants
|
19 participants
|
SECONDARY outcome
Timeframe: between baseline and W48Population: patients with data available
number of patients in different categories of adherence as measured by questionnaire
Outcome measures
| Measure |
Arm A
n=150 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=140 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=159 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Adherence
Always above 95%
|
50 participants
|
54 participants
|
67 participants
|
|
Adherence
At least once 80-95%
|
89 participants
|
72 participants
|
78 participants
|
|
Adherence
At least once < 80%
|
11 participants
|
14 participants
|
4 participants
|
SECONDARY outcome
Timeframe: between W12 and W48Population: patients who failed second line (2 HIV RNA measure above 1000 copies/ml)
number of patients with resistance mutations after second line treatment failure (HIV RNA\> 1000 copies/ml)
Outcome measures
| Measure |
Arm A
n=2 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=2 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=1 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Number of Patients With Resistance Mutations
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: from baseline to week 48Population: population with data available
number of patients developing metabolic syndrome over a period of 48 weeks
Outcome measures
| Measure |
Arm A
n=143 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=132 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=144 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Development of Metabolic Syndrome
|
12 Participants
|
21 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT
Snapshot of patients with HIV viral load less then 50 copies/ml at week 24
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Number of Patients With HIV Plasma Viral Load < 50 Copies/ml
|
90 Participants
|
81 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT
number of patients having a plasma viral load below 200 copies/ml at week 24
Outcome measures
| Measure |
Arm A
n=152 Participants
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 Participants
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 Participants
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Number of Patients With HIV Plasma Viral Load < 200 Copies/ml
|
127 Participants
|
117 Participants
|
129 Participants
|
Adverse Events
Arm A
Serious events: 13 serious events
Other events: 131 other events
Deaths: 0 deaths
Arm B
Serious events: 22 serious events
Other events: 122 other events
Deaths: 0 deaths
Arm C
Serious events: 19 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=152 participants at risk
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 participants at risk
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 participants at risk
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Intracranial injury
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Blood and lymphatic system disorders
Acute posthemorrhagic anemia
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Blood and lymphatic system disorders
Other anaemias
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
1.9%
3/154 • Number of events 3 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Cardiac disorders
Pulmonary embolism
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Endocrine disorders
Unspecified diabetes mellitus
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Gastrointestinal disorders
Other functional intestinal disorders
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Gastrointestinal disorders
Other noninfective gastroenteritis and colitis
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Abdominal and pelvic pain
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Abnormal findings on diagnostic imaging of lung
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Abnormal serum enzyme levels
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Abnormalities of breathing
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Cough
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 2 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Elevated blood glucose level
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Fever of other and unknown origin
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Headache
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Malaise and fatigue
|
1.3%
2/152 • Number of events 2 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Pain in throat and chest
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
1.4%
2/145 • Number of events 2 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Symptoms and signs concerning food and fluid intake
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Unattended death
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
1.4%
2/145 • Number of events 2 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Infectious gastroenteritis and colitis, unspecified
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Other septicaemia
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Respiratory tuberculosis, bacteriologically and histologically confirmed
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Respiratory tuberculosis, not confirmed bacteriologically or histologically
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Tuberculosis of other organs
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
1.4%
2/145 • Number of events 2 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Unspecified malaria
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Injury, poisoning and procedural complications
Medical observation and evaluation for suspected diseases and conditions
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Metabolism and nutrition disorders
Unspecified severe protein- calorie malnutrition
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Metabolism and nutrition disorders
Volume depletion
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of liver and intrahepatic bile ducts
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Pregnancy, puerperium and perinatal conditions
Other abnormal products of conception
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
1.4%
2/145 • Number of events 2 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Renal and urinary disorders
Acute renal failure
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Renal and urinary disorders
Acute tubulo-interstitial nephritis
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Renal and urinary disorders
Other disorders of urinary system
|
1.3%
2/152 • Number of events 2 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Renal and urinary disorders
Unspecified renal failure
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Reproductive system and breast disorders
Excessive, frequent and irregular menstruation
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Reproductive system and breast disorders
Salpingitis and oophoritis
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Bacterial pneumonia, not elsewhere classified
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia in diseases classified elsewhere
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia, organism unspecified
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure, not elsewhere classified
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Skin and subcutaneous tissue disorders
Cutaneous abscess, furuncle and carbuncle
|
0.66%
1/152 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Skin and subcutaneous tissue disorders
Lichen simplex chronicus and prurigo
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/145 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Vascular disorders
Hypotension
|
0.00%
0/152 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.69%
1/145 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.00%
0/154 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
Other adverse events
| Measure |
Arm A
n=152 participants at risk
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
|
Arm B
n=145 participants at risk
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
|
Arm C
n=154 participants at risk
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
7.9%
12/152 • Number of events 13 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
4.8%
7/145 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
4.5%
7/154 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Gastrointestinal disorders
Other functional intestinal disorders
|
10.5%
16/152 • Number of events 19 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
9.7%
14/145 • Number of events 18 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.2%
5/154 • Number of events 5 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Gastrointestinal disorders
Other noninfective gastroenteritis and colitis
|
9.2%
14/152 • Number of events 15 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
2.8%
4/145 • Number of events 4 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
0.65%
1/154 • Number of events 1 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Abdominal and pelvic pain
|
5.9%
9/152 • Number of events 9 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
11.0%
16/145 • Number of events 18 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
5.2%
8/154 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Cough
|
11.2%
17/152 • Number of events 19 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
7.6%
11/145 • Number of events 15 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
10.4%
16/154 • Number of events 21 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Fever of other and unknown origin
|
5.9%
9/152 • Number of events 9 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
5.5%
8/145 • Number of events 9 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
2.6%
4/154 • Number of events 4 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Headache
|
9.2%
14/152 • Number of events 16 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
9.7%
14/145 • Number of events 17 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
10.4%
16/154 • Number of events 19 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Malaise and fatigue
|
7.2%
11/152 • Number of events 12 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
6.2%
9/145 • Number of events 9 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
4.5%
7/154 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Nausea and vomiting
|
5.3%
8/152 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
9.0%
13/145 • Number of events 14 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.9%
6/154 • Number of events 6 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Pain, not elsewhere classified
|
5.9%
9/152 • Number of events 10 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.4%
5/145 • Number of events 5 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.2%
5/154 • Number of events 6 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
General disorders
Symptoms and signs concerning food and fluid intake
|
18.4%
28/152 • Number of events 37 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
16.6%
24/145 • Number of events 28 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
7.1%
11/154 • Number of events 11 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Candidiasis
|
3.3%
5/152 • Number of events 5 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
8.3%
12/145 • Number of events 18 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
8.4%
13/154 • Number of events 16 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Infectious gastroenteritis and colitis, unspecified
|
21.7%
33/152 • Number of events 37 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
15.2%
22/145 • Number of events 25 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
6.5%
10/154 • Number of events 14 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Infections and infestations
Unspecified malaria
|
11.2%
17/152 • Number of events 19 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
6.9%
10/145 • Number of events 13 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
5.8%
9/154 • Number of events 9 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Injury, poisoning and procedural complications
Contraceptive management
|
6.6%
10/152 • Number of events 11 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.4%
5/145 • Number of events 5 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
4.5%
7/154 • Number of events 10 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Injury, poisoning and procedural complications
Pregnancy examination and test
|
3.3%
5/152 • Number of events 5 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
5.5%
8/145 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.2%
5/154 • Number of events 7 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Musculoskeletal and connective tissue disorders
Dorsalgia
|
9.2%
14/152 • Number of events 14 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
2.8%
4/145 • Number of events 4 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
2.6%
4/154 • Number of events 4 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Musculoskeletal and connective tissue disorders
Other joint disorders, not elsewhere classified
|
3.9%
6/152 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
8.3%
12/145 • Number of events 12 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
4.5%
7/154 • Number of events 7 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Nervous system disorders
Other polyneuropathies
|
2.6%
4/152 • Number of events 4 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
6.9%
10/145 • Number of events 10 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
5.2%
8/154 • Number of events 8 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Reproductive system and breast disorders
Other inflammation of vagina and vulva
|
5.9%
9/152 • Number of events 9 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
5.5%
8/145 • Number of events 9 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.2%
5/154 • Number of events 5 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
12.5%
19/152 • Number of events 19 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
10.3%
15/145 • Number of events 16 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
7.1%
11/154 • Number of events 12 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Acute nasopharyngitis [common cold]
|
5.9%
9/152 • Number of events 12 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
4.8%
7/145 • Number of events 7 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
4.5%
7/154 • Number of events 7 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Respiratory, thoracic and mediastinal disorders
Influenza, virus not identified
|
13.2%
20/152 • Number of events 22 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
10.3%
15/145 • Number of events 18 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
10.4%
16/154 • Number of events 19 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Skin and subcutaneous tissue disorders
Cutaneous abscess, furuncle and carbuncle
|
7.9%
12/152 • Number of events 14 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
2.1%
3/145 • Number of events 4 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
3.2%
5/154 • Number of events 5 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Skin and subcutaneous tissue disorders
Lichen simplex chronicus and prurigo
|
7.9%
12/152 • Number of events 14 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
6.2%
9/145 • Number of events 10 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
9.1%
14/154 • Number of events 14 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
18/152 • Number of events 19 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
16.6%
24/145 • Number of events 26 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
11.7%
18/154 • Number of events 22 • 48 Weeks
SAE grade 3, grade 4 and hospitalisation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place