NCT02025868

Third Line Antiretroviral Treatment 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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• HIV Infection

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-08-01
• Completion: 2017-05-01
• First posted: 2014-01-01
• Last updated: 2017-02-17

Locations

7 sites across 4 countries: Burkina Faso, Côte d’Ivoire, Mali, Senegal