Third Line Antiretroviral Threatment Optimization in Sub-Saharan Africa (THILAO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
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:
NCT02025868
First received: December 30, 2013
Last updated: January 2, 2014
Last verified: January 2014

December 30, 2013
January 2, 2014
March 2013
June 2015   (final data collection date for primary outcome measure)
  • Virologic efficacy of the adherence reinforcement intervention [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT02025868 on ClinicalTrials.gov Archive Site
  • Immunological efficacy of the adherence reinforcement intervention [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    CD4 count evolution between inclusion and Week 12
  • Immunological efficacy of 3rd-line ART [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    3rd-line Medication Possession Ratio between Week 16 and Week 64
  • Resistance to 1st and 2nd-line antiretroviral drugs [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64
  • Plasma antiretroviral drugs concentration [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Plasma antiretroviral drugs concentration at Week 12
  • Plasma antiretroviral drugs concentration [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Plasma antiretroviral drugs concentration at Week 64
Same as current
Not Provided
Not Provided
 
Third Line Antiretroviral Threatment Optimization in Sub-Saharan Africa
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.

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.

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:

  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
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • 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)

Experimental: Adherence reinforcement before switch to 3rd-line ART
Interventions:
  • Behavioral: adherence reinforcement
  • Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Raoul Desmoryl Moh, MD, PHD +225 07 82 83 79 raoul.moh@pacci.ci
Contact: Aïda Benalcherif +33 (1) 40 25 63 65 aida.benalycherif@gmail.com
Burkina Faso,   Côte D'Ivoire,   Mali,   Senegal
 
NCT02025868
ANRS 12269 THILAO
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
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
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP