HIV InfectionPhase 2THILAONCT02025868
Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa
A Phase 2 study testing adherence reinforcement and Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 7 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- adherence reinforcement and Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Mar 2013to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- HIV-2 infection
- Any Severe clinical event under exploration
- History of treatment including darunavir or raltegravir.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Burkina Faso2 sites
CHU Sourô Sanou
Bobo-Dioulasso
CHU Yalgado Ouedraogo
Ouagadougou
Côte d’Ivoire2 sites
Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
Abidjan
Service des Maladies Infectieuses et Tropicales (SMIT)
Abidjan
Mali2 sites
Centre d'Ecoute, de Soins, d'Animation et de Conseils (CESAC)
Bamako
CHU Point G
Bamako
About this study
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.
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:
Read more
- 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.
Read the 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:
- The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
- 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) ;
- 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
- Conditions
- HIV Infection
- Being tested
- adherence reinforcement, Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)
- Keywords
- Africa, Antiretroviral Treatment, Adherence reinforcement, Third line ART, Second line ART, Virologic failure, Adults
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adherence reinforcementBehavioural
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)Drug
Second-line ART regimen : ongoing regimen at the time of inclusion will be continued.
Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)
| Study group | Role | What they receive |
|---|---|---|
| Adherence reinforcement before switch to 3rd-line ART | Experimental | Not described Receives: Behavioral: adherence reinforcement; Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic efficacy of the adherence reinforcement intervention
Proportion of patients with plasma viral load <400 copies/ml at Week 12 and/or with a decrease in plasma viral load >2 log10 copies/ml between inclusion and Week 12
Measured: Week 12
Persistent virologic efficacy of the adherence reinforcement intervention
Proportion of patients with plasma viral load <50 copies/ ml at Week 64 among those who stayed on 2nd-line ART at Week 16
Measured: Week 64
Virologic efficacy of 3rd-line ART
Proportion of patients with HIV-1 plasma viral load <50 copies/ml at Week 64 among those with persistent failure at Week 12 who switched to 3rd-line ART
Measured: Week 64
Secondary outcomes (8)
Immunological efficacy of the adherence reinforcement intervention
CD4 count evolution between inclusion and Week 12
Measured: Week 12
Immunological efficacy of 3rd-line ART
CD4 count evolution between Week12 and Week 64 among patients who switched to 3rd-line ART at Week 16
Measured: Week 64
Tolerance of 3rd-line ART drugs
Incidence of grade 3-4 adverse events (ANRS grading table) in patients on 3rd-line ART
Measured: Week 64
Adherence to 3rd-line ART
3rd-line Medication Possession Ratio between Week 16 and Week 64
Measured: Week 64
Resistance to 1st and 2nd-line antiretroviral drugs
Resistance mutations to antiretroviral drugs among patients with virological failure at Week 12
Measured: Week 12
Resistance to 1st, 2nd and 3rd-line antiretroviral drugs
Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64
Measured: Week 64
Plasma antiretroviral drugs concentration
Plasma antiretroviral drugs concentration at Week 12
Measured: Week 12
Plasma antiretroviral drugs concentration
Plasma antiretroviral drugs concentration at Week 64
Measured: Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionAug 2016
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Serge P. Eholie, MD, MSc, Pr, Principal investigator, Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'IvoireRoland Landman, MD, Principal investigator, Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, FranceXavier Anglaret, MD, PhD, Study director, Inserm 897, University of Bordeaux, FrancePierre-Marie Girard, MD, PhD, Study chair, Infectious Diseases Department, University Hospital Saint Antoine, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025868
- Sponsor's protocol ID
- ANRS 12269 THILAO
- Acronym
- THILAO
- Status last verified
- Feb 2017
- First submitted
- 30 Dec 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02025868
- Acronym / sponsor ID
- THILAO / ANRS 12269 THILAO
- Conditions
- HIV Infection
- Keywords
- Africa, Antiretroviral Treatment, Adherence reinforcement, Third line ART, Second line ART, Virologic failure, Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Mar 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
- 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) ;
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adherence reinforcement before switch to 3rd-line ART | Experimental | Behavioral: adherence reinforcement, Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- HIV-2 infection
- Any Severe clinical event under exploration
- History of treatment including darunavir or raltegravir.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adherence reinforcementDirectly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers. | Behavioural | Adherence reinforcement before switch to 3rd-line ART |
| Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)Second-line ART regimen : ongoing regimen at the time of inclusion will be continued. Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) | Drug | Adherence reinforcement before switch to 3rd-line ART |
Primary outcome
Virologic efficacy of the adherence reinforcement intervention
Time frame: Week 12
Proportion of patients with plasma viral load <400 copies/ml at Week 12 and/or with a decrease in plasma viral load >2 log10 copies/ml between inclusion and Week 12
Persistent virologic efficacy of the adherence reinforcement intervention
Time frame: Week 64
Proportion of patients with plasma viral load <50 copies/ ml at Week 64 among those who stayed on 2nd-line ART at Week 16
Virologic efficacy of 3rd-line ART
Time frame: Week 64
Proportion of patients with HIV-1 plasma viral load <50 copies/ml at Week 64 among those with persistent failure at Week 12 who switched to 3rd-line ART
8 secondary outcomes
Immunological efficacy of the adherence reinforcement intervention
Time frame: Week 12
Immunological efficacy of 3rd-line ART
Time frame: Week 64
Tolerance of 3rd-line ART drugs
Time frame: Week 64
Adherence to 3rd-line ART
Time frame: Week 64
Resistance to 1st and 2nd-line antiretroviral drugs
Time frame: Week 12
Resistance to 1st, 2nd and 3rd-line antiretroviral drugs
Time frame: Week 64
Plasma antiretroviral drugs concentration
Time frame: Week 12
Plasma antiretroviral drugs concentration
Time frame: Week 64
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Sponsor siteLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge P. Eholie, MD, MSc, Pr principal investigator
Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
Roland Landman, MD principal investigator
Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France
Xavier Anglaret, MD, PhD study director
Inserm 897, University of Bordeaux, France
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adherence reinforcement and Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators) in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Burkina Faso, Côte d’Ivoire, Mali, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic efficacy of the adherence reinforcement intervention (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.