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Status unknownNCT02025868THILAOUpdated Feb 17, 2017

Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

A Phase 2 interventional study of adherence reinforcement and Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) in HIV Infection, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
201
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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
02

Conditions studied

  • HIV Infection

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Keywords

  • Africa
  • Antiretroviral Treatment
  • Adherence reinforcement
  • Third line ART
  • Second line ART
  • Virologic failure
  • Adults
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 201 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • HIV-2 infection
  • Any Severe clinical event under exploration
  • History of treatment including darunavir or raltegravir.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
201 participants (actual)

Study arms

  • Experimental
    Adherence reinforcement before switch to 3rd-line ART

    Behavioral: adherence reinforcement · Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Interventions

  • Behavioraladherence reinforcement

    Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.

  • DrugAntiretroviral 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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Week 12

  2. 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

    Time frame: Week 64

  3. 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

    Time frame: Week 64

Secondary outcomes

  1. Immunological efficacy of the adherence reinforcement intervention

    CD4 count evolution between inclusion and Week 12

    Time frame: Week 12

  2. 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

    Time frame: Week 64

  3. Tolerance of 3rd-line ART drugs

    Incidence of grade 3-4 adverse events (ANRS grading table) in patients on 3rd-line ART

    Time frame: Week 64

  4. Adherence to 3rd-line ART

    3rd-line Medication Possession Ratio between Week 16 and Week 64

    Time frame: Week 64

  5. Resistance to 1st and 2nd-line antiretroviral drugs

    Resistance mutations to antiretroviral drugs among patients with virological failure at Week 12

    Time frame: Week 12

  6. Resistance to 1st, 2nd and 3rd-line antiretroviral drugs

    Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64

    Time frame: Week 64

  7. Plasma antiretroviral drugs concentration

    Plasma antiretroviral drugs concentration at Week 12

    Time frame: Week 12

  8. Plasma antiretroviral drugs concentration

    Plasma antiretroviral drugs concentration at Week 64

    Time frame: Week 64

07

Study locations

7 sites
  • 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
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02025868
Lead sponsor
ANRS, Emerging Infectious Diseases
Responsible party
Sponsor
First posted
Jan 1, 2014
Start date
Mar 2013
Primary completion
Aug 2016
Completion
May 2017 (estimated)
Last update
Feb 17, 2017

Study contacts

Serge P. Eholie, MD, MSc, Pr
principal investigator · Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
Roland Landman, MD
principal investigator · Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France
Xavier Anglaret, MD, PhD
study director · Inserm 897, University of Bordeaux, France
Pierre-Marie Girard, MD, PhD
study chair · Infectious Diseases Department, University Hospital Saint Antoine, Paris, France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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