Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa (THILAO)
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|ClinicalTrials.gov Identifier: NCT02025868|
Recruitment Status : Unknown
Verified February 2017 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was: Active, not recruiting
First Posted : January 1, 2014
Last Update Posted : February 17, 2017
Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa.
HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases:
- First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers;
Second, a 48-week phase, during which:
- Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement;
- Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART.
Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Behavioral: adherence reinforcement Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)||Phase 2|
To estimate, in sub-Saharan African HIV-1 infected adults who failed a NNRTI-base first-line ART and then a PI-based second-line ART:
- The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
- In patients who successfully resuppress at 12 weeks: The percentage of patients still with continuing succesfull virologic supression on 2nd-line ART at 64 weeks (and factors associated to success) ;
- In patients with persistent failure at 12 weeks : The efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen.
Number of participants : 200
Main outcome :
- At 12 weeks : Proportion of patients with a plasma HIV-1 RNA <400 copies/ml and/or with a decrease in plasma HIV-1 RNA >2 log10 copies/ml between inclusion and 12 weeks;
- At 64 weeks : proportion of patients with a plasma HIV-1 RNA <50 copies/ml.
- Age >18 years
- Documented HIV-1 infection.
- History of failing a NNRTI-based 1st-line ART
- Current PI-based 2nd-line ART >6 months
- Plasma HIV-1 RNA >1000 copies/ml
- Signed informed consent
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Systematic "Adherence Intervention" Phase Before Switching to 3rd-line ART in Patients With 2nd-line ART Virologic Failure in Sub-Saharan Africa : a Phase 2b Non-randomized Study.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||May 2017|
|Experimental: Adherence reinforcement before switch to 3rd-line ART||
Behavioral: adherence reinforcement
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)
Second-line ART regimen : ongoing regimen at the time of inclusion will be continued.
Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)
- Virologic efficacy of the adherence reinforcement intervention [ Time Frame: Week 12 ]Proportion of patients with plasma viral load <400 copies/ml at Week 12 and/or with a decrease in plasma viral load >2 log10 copies/ml between inclusion and Week 12
- Persistent virologic efficacy of the adherence reinforcement intervention [ Time Frame: Week 64 ]Proportion of patients with plasma viral load <50 copies/ ml at Week 64 among those who stayed on 2nd-line ART at Week 16
- Virologic efficacy of 3rd-line ART [ Time Frame: Week 64 ]Proportion of patients with HIV-1 plasma viral load <50 copies/ml at Week 64 among those with persistent failure at Week 12 who switched to 3rd-line ART
- Immunological efficacy of the adherence reinforcement intervention [ Time Frame: Week 12 ]CD4 count evolution between inclusion and Week 12
- Immunological efficacy of 3rd-line ART [ Time Frame: Week 64 ]CD4 count evolution between Week12 and Week 64 among patients who switched to 3rd-line ART at Week 16
- Tolerance of 3rd-line ART drugs [ Time Frame: Week 64 ]Incidence of grade 3-4 adverse events (ANRS grading table) in patients on 3rd-line ART
- Adherence to 3rd-line ART [ Time Frame: Week 64 ]3rd-line Medication Possession Ratio between Week 16 and Week 64
- Resistance to 1st and 2nd-line antiretroviral drugs [ Time Frame: Week 12 ]Resistance mutations to antiretroviral drugs among patients with virological failure at Week 12
- Resistance to 1st, 2nd and 3rd-line antiretroviral drugs [ Time Frame: Week 64 ]Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64
- Plasma antiretroviral drugs concentration [ Time Frame: Week 12 ]Plasma antiretroviral drugs concentration at Week 12
- Plasma antiretroviral drugs concentration [ Time Frame: Week 64 ]Plasma antiretroviral drugs concentration at Week 64
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025868
|CHU Sourô Sanou|
|Bobo-Dioulasso, Burkina Faso|
|CHU Yalgado Ouedraogo|
|Ouagadougou, Burkina Faso|
|Centre de Prise en Charge et de Formation (CePReF), Association ACONDA|
|Abidjan, Côte D'Ivoire|
|Service des Maladies Infectieuses et Tropicales (SMIT)|
|Abidjan, Côte D'Ivoire|
|Centre d'Ecoute, de Soins, d'Animation et de Conseils (CESAC)|
|CHU Point G|
|Principal Investigator:||Serge P. Eholie, MD, MSc, Pr||Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire|
|Principal Investigator:||Roland Landman, MD||Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France|
|Study Director:||Xavier Anglaret, MD, PhD||Inserm 897, University of Bordeaux, France|
|Study Chair:||Pierre-Marie Girard, MD, PhD||Infectious Diseases Department, University Hospital Saint Antoine, Paris, France|