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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:
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.
Main objective
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:
Number of participants : 200
Main outcome :
Inclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adherence reinforcement before switch to 3rd-line ART | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adherence reinforcement | Behavioral | Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers. |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic efficacy of the adherence reinforcement intervention | 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 | Week 12 |
| Persistent virologic efficacy of the adherence reinforcement intervention | Proportion of patients with plasma viral load <50 copies/ ml at Week 64 among those who stayed on 2nd-line ART at Week 16 | Week 64 |
| Virologic efficacy of 3rd-line ART | 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 | Week 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological efficacy of the adherence reinforcement intervention | CD4 count evolution between inclusion and Week 12 | Week 12 |
| Immunological efficacy of 3rd-line ART | CD4 count evolution between Week12 and Week 64 among patients who switched to 3rd-line ART at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Xavier Anglaret, MD, PhD | Inserm 897, University of Bordeaux, France | Study Director |
| Pierre-Marie Girard, MD, PhD | Infectious Diseases Department, University Hospital Saint Antoine, Paris, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sourô Sanou | Bobo-Dioulasso | Burkina Faso | ||||
| CHU Yalgado Ouedraogo |
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| Label | URL |
|---|---|
| Sponsor site | View source |
| Related Info | View source |
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| Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) | Drug | 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) |
|
| Week 64 |
| Tolerance of 3rd-line ART drugs | Incidence of grade 3-4 adverse events (ANRS grading table) in patients on 3rd-line ART | Week 64 |
| Adherence to 3rd-line ART | 3rd-line Medication Possession Ratio between Week 16 and Week 64 | Week 64 |
| Resistance to 1st and 2nd-line antiretroviral drugs | Resistance mutations to antiretroviral drugs among patients with virological failure at Week 12 | Week 12 |
| Resistance to 1st, 2nd and 3rd-line antiretroviral drugs | Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64 | Week 64 |
| Plasma antiretroviral drugs concentration | Plasma antiretroviral drugs concentration at Week 12 | Week 12 |
| Plasma antiretroviral drugs concentration | Plasma antiretroviral drugs concentration at Week 64 | Week 64 |
| 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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