drugset / Trial / NCT02025868

Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

NCT02025868

Phase 2 Unknown 201 enrolled ANRS, Emerging Infectious Diseases
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-03
Primary completion
2016-08
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule
Subject Raltegravir Other / unclassified