Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

NCT02025868 | Unknown Phase 2 DMC

• 1 other identifier: ANRS 12269 THILAO
• Study Type: interventional
• Target: 201
• Locations: 4 countries
• Sites: 7

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.

Conditions

HIV Infection

Keywords

Africa; Antiretroviral Treatment; Adherence reinforcement; Third line ART; Second line ART; Virologic failure; Adults

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Week 64

Secondary Outcomes (8)

• Immunological efficacy of the adherence reinforcement intervention

  Week 12

• Immunological efficacy of 3rd-line ART

  Week 64

• Tolerance of 3rd-line ART drugs

  Week 64

• Adherence to 3rd-line ART

  Week 64

• Resistance to 1st and 2nd-line antiretroviral drugs

  Week 12

Study Arms (1)

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)

Interventions

adherence reinforcement BEHAVIORAL

Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.

Adherence reinforcement before switch to 3rd-line ART

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)

Adherence reinforcement before switch to 3rd-line ART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HIV-2 infection
• Any Severe clinical event under exploration
• History of treatment including darunavir or raltegravir.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (7)

CHU Sourô Sanou

Bobo-Dioulasso, Burkina Faso

Location

CHU Yalgado Ouedraogo

Ouagadougou, Burkina Faso

Location

Centre de Prise en Charge et de Formation (CePReF), Association ACONDA

Abidjan, Côte d’Ivoire

Location

Service des Maladies Infectieuses et Tropicales (SMIT)

Abidjan, Côte d’Ivoire

Location

Centre d'Ecoute, de Soins, d'Animation et de Conseils (CESAC)

Bamako, Mali

Location

CHU Point G

Bamako, Mali

Location

CHU Fann

Dakar, Senegal

Location

Related Links

• Sponsor site
• Related Info

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Serge P. Eholie, MD, MSc, Pr

  Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire

  PRINCIPAL INVESTIGATOR

• Roland Landman, MD

  Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France

  PRINCIPAL INVESTIGATOR

• Xavier Anglaret, MD, PhD

  Inserm 897, University of Bordeaux, France

  STUDY DIRECTOR

• Pierre-Marie Girard, MD, PhD

  Infectious Diseases Department, University Hospital Saint Antoine, Paris, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 1, 2014
• Study Start: March 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: May 1, 2017
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

CÔ (2); BU (2); SE (1); MA (2)