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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02025868 |
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Date of registration:
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30/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa
THILAO |
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Scientific title:
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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. |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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201 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02025868 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Burkina Faso
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Côte D'Ivoire
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Mali
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Senegal
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Contacts
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Name:
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Roland Landman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France |
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Name:
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Pierre-Marie Girard, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Infectious Diseases Department, University Hospital Saint Antoine, Paris, France |
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Name:
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Xavier Anglaret, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inserm 897, University of Bordeaux, France |
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Name:
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Serge P. Eholie, MD, MSc, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire |
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Key inclusion & exclusion criteria
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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
Exclusion Criteria:
- HIV-2 infection
- Any Severe clinical event under exploration
- History of treatment including darunavir or raltegravir.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Infection
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Intervention(s)
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Behavioral: adherence reinforcement
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Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)
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Primary Outcome(s)
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Persistent virologic efficacy of the adherence reinforcement intervention
[Time Frame: Week 64]
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Virologic efficacy of the adherence reinforcement intervention
[Time Frame: Week 12]
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Virologic efficacy of 3rd-line ART
[Time Frame: Week 64]
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Secondary Outcome(s)
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Plasma antiretroviral drugs concentration
[Time Frame: Week 12]
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Plasma antiretroviral drugs concentration
[Time Frame: Week 64]
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Tolerance of 3rd-line ART drugs
[Time Frame: Week 64]
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Adherence to 3rd-line ART
[Time Frame: Week 64]
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Resistance to 1st and 2nd-line antiretroviral drugs
[Time Frame: Week 12]
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Immunological efficacy of the adherence reinforcement intervention
[Time Frame: Week 12]
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Resistance to 1st, 2nd and 3rd-line antiretroviral drugs
[Time Frame: Week 64]
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Immunological efficacy of 3rd-line ART
[Time Frame: Week 64]
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Secondary ID(s)
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ANRS 12269 THILAO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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