Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-02-02 @ 11:42 AM
Study NCT ID:
NCT02025868
Status:
UNKNOWN
Last Update Posted:
2017-02-17
First Post:
2013-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THILAO
Brief 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.
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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: