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

This study has been completed.
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)
ClinicalTrials.gov Identifier:
NCT00928187
First received: June 23, 2009
Last updated: September 21, 2016
Last verified: September 2016
Results First Received: July 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment in three study sites (Yaoundé, Dakar and Bobo Dioulasso) in HIV day care clinics from January 2010 to September 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
584 patients assessed for eligibility, 130 excluded primary (13.9%) because control viral load decreased below 1000 copies/mL after adherence support.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Arm A   Arm B   Arm C
STARTED   152   147   155 
Analysed   152   145   154 
COMPLETED   150   141   150 
NOT COMPLETED   2   6   5 
Death                1                2                3 
Lost to Follow-up                1                2                1 
Withdrawal by Subject                0                1                1 
Protocol Violation                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Arm C   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   145   154   451 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 38 
 (34 to 45) 
 38 
 (33 to 47) 
 36 
 (32 to 45) 
 38 
 (32 to 46) 
Gender 
[Units: Participants]
       
Female   113   105   106   324 
Male   39   40   48   127 
Region of Enrollment 
[Units: Participants]
       
Cameroon   101   99   102   302 
Burkina Faso   30   28   32   90 
Senegal   21   18   20   59 
HIV RNA Viral Load 
[Units: Log10 (copies/ml)]
Median (Inter-Quartile Range)
 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 
[Units: Participants]
 84   77   88   249 
CD4 cells count 
[Units: Cells/mm3]
Median (Inter-Quartile Range)
 199 
 (92 to 318) 
 195 
 (100 to 288) 
 153 
 (81 to 261) 
 183 
 (87 to 290) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Plasma HIV RNA < 50 Copies/mL   [ Time Frame: 48 weeks ]

2.  Secondary:   Number of Patients With WHO Stage 3 and 4 HIV Related Events   [ Time Frame: between baseline and 48 weeks ]

3.  Secondary:   Patients With Plasma HIV RNA < 200 Copies/ml   [ Time Frame: 48 weeks ]

4.  Secondary:   Gain in CD4 Cells Between Baseline and W48   [ Time Frame: between baseline and 48 weeks ]

5.  Secondary:   Number of Patients Discontinuing Study Treatment   [ Time Frame: between baseline and W48 ]

6.  Secondary:   Tolerance: Gastrointestinal Complains   [ Time Frame: between baseline and 48 weeks ]

7.  Secondary:   Tolerance: Neuropathies (Grade 1 to 4)   [ Time Frame: between baseline and W48 ]

8.  Secondary:   Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)   [ Time Frame: between baseline and W48 ]

9.  Secondary:   Adherence   [ Time Frame: between baseline and W48 ]

10.  Secondary:   Number of Patients With Resistance Mutations   [ Time Frame: between W12 and W48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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%).


  More Information
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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
e-mail: lauraciaffi2002@yahoo.fr



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
Study First Received: June 23, 2009
Results First Received: July 11, 2016
Last Updated: September 21, 2016
Health Authority: Cameroon: Ministry of Public Health