Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa — THILAO  

HIV Infection Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

• NCT number: NCT02025868
• Study type: Interventional
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2013
• Completion date: May 2017