Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa
NCT ID: NCT02025868
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
201 participants
INTERVENTIONAL
2013-03-31
2017-05-31
Brief Summary
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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.
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Detailed Description
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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:
1. The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
2. 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) ;
3. 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.
Inclusion criteria:
* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adherence reinforcement before switch to 3rd-line ART
adherence reinforcement
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
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)
Interventions
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adherence reinforcement
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Any Severe clinical event under exploration
* History of treatment including darunavir or raltegravir.
18 Years
ALL
No
Sponsors
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ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Serge P. Eholie, MD, MSc, Pr
Role: PRINCIPAL_INVESTIGATOR
Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
Roland Landman, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France
Xavier Anglaret, MD, PhD
Role: STUDY_DIRECTOR
Inserm 897, University of Bordeaux, France
Pierre-Marie Girard, MD, PhD
Role: STUDY_CHAIR
Infectious Diseases Department, University Hospital Saint Antoine, Paris, France
Locations
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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)
Bamako, , Mali
CHU Point G
Bamako, , Mali
CHU Fann
Dakar, , Senegal
Countries
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Related Links
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Sponsor site
Related Info
Other Identifiers
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ANRS 12269 THILAO
Identifier Type: -
Identifier Source: org_study_id
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