Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa (THILAO)

ANRS, Emerging Infectious Diseases

Status and phase: Unknown; Phase 2

Conditions: HIV Infection

Treatments: Behavioral: adherence reinforcement; Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Study type: Interventional

Funder types: Other

Identifiers

NCT02025868

ANRS 12269 THILAO

Details and patient eligibility

About

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.

Full 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

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

201 participants in 1 patient group

Adherence reinforcement before switch to 3rd-line ART

Experimental group

Treatment:

Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Behavioral: adherence reinforcement