Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

• Status: Unknown status
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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)
• Treatments: Anti-Retroviral Agents; Darunavir; Raltegravir Potassium

Criteria

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.