Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa
Status:
Unknown status
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)