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Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé) (2LADY)

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ClinicalTrials.gov Identifier: NCT00928187
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : November 8, 2016
Last Update Posted : February 27, 2017
Sponsor:
Collaborators:
Gilead Sciences
Janssen Pharmaceutica
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Interventions Drug: emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
Drug: abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
Drug: emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
Enrollment 454
Recruitment Details Recruitment in three study sites (Yaoundé, Dakar and Bobo Dioulasso) in HIV day care clinics from January 2010 to September 2012.
Pre-assignment Details 584 patients assessed for eligibility, 130 excluded primary (13.9%) because control viral load decreased below 1000 copies/mL after adherence support.
Arm/Group Title Arm A Arm B Arm C
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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

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

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

Period Title: Overall Study
Started 152 147 155
Analysed 152 145 154
Completed 150 141 150
Not Completed 2 6 5
Reason Not Completed
Death             1             2             3
Lost to Follow-up             1             2             1
Withdrawal by Subject             0             1             1
Protocol Violation             0             1             0
Arm/Group Title Arm A Arm B Arm C Total
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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

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

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 of all reporting groups
Overall Number of Baseline Participants 152 145 154 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 152 participants 145 participants 154 participants 451 participants
38
(34 to 45)
38
(33 to 47)
36
(32 to 45)
38
(32 to 46)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 145 participants 154 participants 451 participants
Female
113
  74.3%
105
  72.4%
106
  68.8%
324
  71.8%
Male
39
  25.7%
40
  27.6%
48
  31.2%
127
  28.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 145 participants 154 participants 451 participants
Cameroon 101 99 102 302
Burkina Faso 30 28 32 90
Senegal 21 18 20 59
HIV RNA Viral Load  
Median (Inter-Quartile Range)
Unit of measure:  Log10 (copies/ml)
Number Analyzed 152 participants 145 participants 154 participants 451 participants
4.4
(4.0 to 5.0)
4.6
(4.1 to 5.1)
4.5
(4.0 to 5.1)
4.5
(4.0 to 5.1)
Resistance to the three first-line drugs  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 145 participants 154 participants 451 participants
84 77 88 249
CD4 cells count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm3
Number Analyzed 152 participants 145 participants 154 participants 451 participants
199
(92 to 318)
195
(100 to 288)
153
(81 to 261)
183
(87 to 290)
1.Primary Outcome
Title Number of Patients With Plasma HIV RNA < 50 Copies/mL
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
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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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Number
Unit of Measure: participants
105 92 97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Hypothesizing 80% efficacy at the 50 copies/mL Viral Load (VL) threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.
Method of Estimation Estimation Parameter differences in proportions
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-5.1 to 16.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A, Arm C
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.
Method of Estimation Estimation Parameter difference in proportions
Estimated Value 6.1
Confidence Interval (2-Sided) 95%
-4.5 to 16.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With WHO Stage 3 and 4 HIV Related Events
Hide Description patients having a diagnosis of HIV related event classified as stage 3 or 4
Time Frame between baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
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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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Number
Unit of Measure: participants
17 23 30
3.Secondary Outcome
Title Patients With Plasma HIV RNA < 200 Copies/ml
Hide Description number of patients with plasma HIV RNA below 200 copies/ml
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Number
Unit of Measure: participants
130 118 127
4.Secondary Outcome
Title Gain in CD4 Cells Between Baseline and W48
Hide Description median gain in circulating CD4 cells between baseline and W48
Time Frame between baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT with data available
Arm/Group Title Arm A Arm B Arm C
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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

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

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 Number of Participants Analyzed 150 140 149
Median (Inter-Quartile Range)
Unit of Measure: cell/mm3
133
(82 to 220)
136
(78 to 206)
115
(58 to 187)
5.Secondary Outcome
Title Number of Patients Discontinuing Study Treatment
Hide Description number of patients discounting treatment because of adverse events
Time Frame between baseline and W48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
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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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Number
Unit of Measure: participants
0 4 1
6.Secondary Outcome
Title Tolerance: Gastrointestinal Complains
Hide Description Gastrointestinal complaints (grade 1 to 4) between baseline and W48.
Time Frame between baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
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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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Number
Unit of Measure: participants
50 48 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B, Arm C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Tolerance: Neuropathies (Grade 1 to 4)
Hide Description any symptom of peripheral neuropathy
Time Frame between baseline and W48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
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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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Number
Unit of Measure: participants
5 11 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B, Arm C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
Hide Description evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value
Time Frame between baseline and W48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Number
Unit of Measure: participants
28 14 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B, Arm C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Adherence
Hide Description number of patients in different categories of adherence as measured by questionnaire
Time Frame between baseline and W48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients with data available
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 150 140 159
Measure Type: Number
Unit of Measure: participants
Always above 95% 50 54 67
At least once 80-95% 89 72 78
At least once < 80% 11 14 4
10.Secondary Outcome
Title Number of Patients With Resistance Mutations
Hide Description number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml)
Time Frame between W12 and W48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients who failed second line (2 HIV RNA measure above 1000 copies/ml)
Arm/Group Title Arm A Arm B Arm C
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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

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

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 Number of Participants Analyzed 2 2 1
Measure Type: Number
Unit of Measure: participants
0 0 0
11.Secondary Outcome
Title Development of Metabolic Syndrome
Hide Description number of patients developing metabolic syndrome over a period of 48 weeks
Time Frame from baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
population with data available
Arm/Group Title Arm A Arm B Arm C
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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

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

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 Number of Participants Analyzed 143 132 144
Measure Type: Count of Participants
Unit of Measure: Participants
12
   8.4%
21
  15.9%
9
   6.3%
12.Secondary Outcome
Title Number of Patients With HIV Plasma Viral Load < 50 Copies/ml
Hide Description Snapshot of patients with HIV viral load less then 50 copies/ml at week 24
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Count of Participants
Unit of Measure: Participants
90
  59.2%
81
  55.9%
97
  63.0%
13.Secondary Outcome
Title Number of Patients With HIV Plasma Viral Load < 200 Copies/ml
Hide Description number of patients having a plasma viral load below 200 copies/ml at week 24
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 152 145 154
Measure Type: Count of Participants
Unit of Measure: Participants
127
  83.6%
117
  80.7%
129
  83.8%
Time Frame 48 Weeks
Adverse Event Reporting Description SAE grade 3, grade 4 and hospitalisation
 
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Arm A Arm B Arm C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/152 (8.55%)      22/145 (15.17%)      19/154 (12.34%)    
Blood and lymphatic system disorders       
Acute posthemorrhagic anemia * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Other anaemias * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 3/154 (1.95%)  3
Cardiac disorders       
Pulmonary embolism * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Endocrine disorders       
Unspecified diabetes mellitus * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Gastrointestinal disorders       
Other functional intestinal disorders * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Other noninfective gastroenteritis and colitis * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
General disorders       
Abdominal and pelvic pain * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Abnormal findings on diagnostic imaging of lung * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Abnormal serum enzyme levels * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
Abnormalities of breathing * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Cough * 1  0/152 (0.00%)  0 1/145 (0.69%)  2 1/154 (0.65%)  1
Elevated blood glucose level * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Fever of other and unknown origin * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Headache * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 1/154 (0.65%)  1
Malaise and fatigue * 1  2/152 (1.32%)  2 1/145 (0.69%)  1 1/154 (0.65%)  1
Pain in throat and chest * 1  0/152 (0.00%)  0 2/145 (1.38%)  2 1/154 (0.65%)  1
Symptoms and signs concerning food and fluid intake * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Unattended death * 1  1/152 (0.66%)  1 2/145 (1.38%)  2 1/154 (0.65%)  1
Infections and infestations       
Infectious gastroenteritis and colitis, unspecified * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
Other septicaemia * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Respiratory tuberculosis, bacteriologically and histologically confirmed * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Respiratory tuberculosis, not confirmed bacteriologically or histologically * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Tuberculosis of other organs * 1  0/152 (0.00%)  0 2/145 (1.38%)  2 0/154 (0.00%)  0
Unspecified malaria * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
Injury, poisoning and procedural complications       
Intracranial injury * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
Medical observation and evaluation for suspected diseases and conditions * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Metabolism and nutrition disorders       
Unspecified severe protein- calorie malnutrition * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Volume depletion * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant neoplasm of liver and intrahepatic bile ducts * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Other abnormal products of conception * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Spontaneous abortion * 1  0/152 (0.00%)  0 2/145 (1.38%)  2 0/154 (0.00%)  0
Renal and urinary disorders       
Acute renal failure * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
Acute tubulo-interstitial nephritis * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Other disorders of urinary system * 1  2/152 (1.32%)  2 0/145 (0.00%)  0 0/154 (0.00%)  0
Unspecified renal failure * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Reproductive system and breast disorders       
Excessive, frequent and irregular menstruation * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Salpingitis and oophoritis * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Bacterial pneumonia, not elsewhere classified * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 1/154 (0.65%)  1
Pneumonia in diseases classified elsewhere * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Pneumonia, organism unspecified * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
Respiratory failure, not elsewhere classified * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Skin and subcutaneous tissue disorders       
Cutaneous abscess, furuncle and carbuncle * 1  1/152 (0.66%)  1 0/145 (0.00%)  0 0/154 (0.00%)  0
Decubitus ulcer * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Lichen simplex chronicus and prurigo * 1  0/152 (0.00%)  0 0/145 (0.00%)  0 1/154 (0.65%)  1
Vascular disorders       
Hypotension * 1  0/152 (0.00%)  0 1/145 (0.69%)  1 0/154 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CIM 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   131/152 (86.18%)      122/145 (84.14%)      118/154 (76.62%)    
Blood and lymphatic system disorders       
Agranulocytosis * 1  12/152 (7.89%)  13 7/145 (4.83%)  8 7/154 (4.55%)  8
Gastrointestinal disorders       
Other functional intestinal disorders * 1  16/152 (10.53%)  19 14/145 (9.66%)  18 5/154 (3.25%)  5
Other noninfective gastroenteritis and colitis * 1  14/152 (9.21%)  15 4/145 (2.76%)  4 1/154 (0.65%)  1
General disorders       
Abdominal and pelvic pain * 1  9/152 (5.92%)  9 16/145 (11.03%)  18 8/154 (5.19%)  8
Cough * 1  17/152 (11.18%)  19 11/145 (7.59%)  15 16/154 (10.39%)  21
Fever of other and unknown origin * 1  9/152 (5.92%)  9 8/145 (5.52%)  9 4/154 (2.60%)  4
Headache * 1  14/152 (9.21%)  16 14/145 (9.66%)  17 16/154 (10.39%)  19
Malaise and fatigue * 1  11/152 (7.24%)  12 9/145 (6.21%)  9 7/154 (4.55%)  8
Nausea and vomiting * 1  8/152 (5.26%)  8 13/145 (8.97%)  14 6/154 (3.90%)  6
Pain, not elsewhere classified * 1  9/152 (5.92%)  10 5/145 (3.45%)  5 5/154 (3.25%)  6
Symptoms and signs concerning food and fluid intake * 1  28/152 (18.42%)  37 24/145 (16.55%)  28 11/154 (7.14%)  11
Infections and infestations       
Candidiasis * 1  5/152 (3.29%)  5 12/145 (8.28%)  18 13/154 (8.44%)  16
Infectious gastroenteritis and colitis, unspecified * 1  33/152 (21.71%)  37 22/145 (15.17%)  25 10/154 (6.49%)  14
Unspecified malaria * 1  17/152 (11.18%)  19 10/145 (6.90%)  13 9/154 (5.84%)  9
Injury, poisoning and procedural complications       
Contraceptive management * 1  10/152 (6.58%)  11 5/145 (3.45%)  5 7/154 (4.55%)  10
Pregnancy examination and test * 1  5/152 (3.29%)  5 8/145 (5.52%)  8 5/154 (3.25%)  7
Musculoskeletal and connective tissue disorders       
Dorsalgia * 1  14/152 (9.21%)  14 4/145 (2.76%)  4 4/154 (2.60%)  4
Other joint disorders, not elsewhere classified * 1  6/152 (3.95%)  8 12/145 (8.28%)  12 7/154 (4.55%)  7
Nervous system disorders       
Other polyneuropathies * 1  4/152 (2.63%)  4 10/145 (6.90%)  10 8/154 (5.19%)  8
Reproductive system and breast disorders       
Other inflammation of vagina and vulva * 1  9/152 (5.92%)  9 8/145 (5.52%)  9 5/154 (3.25%)  5
Respiratory, thoracic and mediastinal disorders       
Acute bronchitis * 1  19/152 (12.50%)  19 15/145 (10.34%)  16 11/154 (7.14%)  12
Acute nasopharyngitis [common cold] * 1  9/152 (5.92%)  12 7/145 (4.83%)  7 7/154 (4.55%)  7
Influenza, virus not identified * 1  20/152 (13.16%)  22 15/145 (10.34%)  18 16/154 (10.39%)  19
Skin and subcutaneous tissue disorders       
Cutaneous abscess, furuncle and carbuncle * 1  12/152 (7.89%)  14 3/145 (2.07%)  4 5/154 (3.25%)  5
Lichen simplex chronicus and prurigo * 1  12/152 (7.89%)  14 9/145 (6.21%)  10 14/154 (9.09%)  14
Pruritus * 1  18/152 (11.84%)  19 24/145 (16.55%)  26 18/154 (11.69%)  22
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CIM10
Limitations: open label design, random imbalance at baseline. Non-inferiority not shown, results influenced by the hypothesis of 80% viral success (50 copies/mL), not reached (69% in the control group). Therefore, the study power was reduced (80%).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Laura Ciaffi
Organization: UMI 233 IRD Montpellier
Phone: 00237 694926786
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT00928187     History of Changes
Other Study ID Numbers: ANRS12169 2LADY
First Submitted: June 23, 2009
First Posted: June 25, 2009
Results First Submitted: July 11, 2016
Results First Posted: November 8, 2016
Last Update Posted: February 27, 2017