Clinical trial NCT02150993: First-Line Treatment for HIV-2
Official title: A Randomized, Non-comparative, Phase IIb, Unblinded Trial, Evaluating the Efficacy and Safety of Tenofovir-emtricitabine or Lamivudine Plus Zidovudine, Lopinavir/Ritonavir, or Raltegravir, Among ARV-naïve HIV-2 Infected Adult Patients, in West Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV-2 Infection
Keywords: Africa
Antiretroviral Treatment
HIV-2
firsts line ART
Adults
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2014-05-30
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo).

ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks.

The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2 infected adult patients, in West Africa. A treatment will be considered as effective if more than 55% of patients in that arm attain "global success" at 96 weeks.

Detailed description: Main objective

To determine in treatment-naïve HIV-2 infected patients, with CD4 counts above 200 cells/mm3, which of the following three regimens of first line treatment, Tenofovir (TDF), Emtricitabine or lamivudine (FTC or 3TC) plus Zidovudine (ZDV); TDF-FTC (3TC) plus Lopinavir/ritonavir (LPV / r); or TDF-FTC (3TC) plus raltegravir (RAL), will result in an "global success" rate of \> 55% at week 96.

Number of participants : 210

Main outcome :

The proportion of patients with "global success" at W96, defined by survival with a plasma HIV-2 RNA viral load of \<50 copies/ml and the non-occurrence of AIDS classified events (excluding tuberculosis) and the non-occurrence of severe morbidities non-AIDS-defining illness (cardiovascular disease, kidney disease, severe bacterial disease) and a delta of CD4 depending on the initial CD4 count (CD4 delta \> +100cells/mm3 for initial CD4s between 201 and 500 cells/mm3 or delta ≥0 cells/mm3 for initial CD4s \> +500 cells/mm3)

Inclusion criteria:

* Infection by HIV-2 only;
* Age \> or = 18 years;
* Naïve for antiretroviral therapy (including antiretroviral treatment in the context of PMTCT except taking a dose of Nevirapine for PMTCT)
* CD4 \>200 cells/mm3
* Resident of the city where the study is held or of city suburbs to facilitate participation
* Signed informed consent document

Eligibility criteria: Inclusion Criteria:

* Infection by HIV-2 only;
* Age \> ou = 18 years;
* Naïve for antiretroviral therapy (including antiretroviral treatment in the context of PMTCT except taking a dose of Nevirapine for PMTCT)
* CD4 \>200 cells/mm3
* Resident of the city where the study is held or of city suburbs to facilitate participation
* Signed informed consent document

Exclusion Criteria:

* Current participation in any other clinical trial
* Presence of opportunistic non-stabilized infections, of any serious or progressive disease, or of any clinical signs consistent with severe disease whose diagnosis is not yet confirmed, such as fever, weight loss, diarrhea or cough not yet explained (non-exhaustive list).
* All pathology that leads in daily life to prefer one or the other of the three therapeutic regimens for medical reasons or to change the dosages specified in the test. This includes (but not limited to):
* Hemoglobin ≤ 8 g / dL
* Neutrophil count \<500 cells/mm3
* Renal impairment with creatinine clearance \<50mL/mn
* Blood platelet \<50 000 cells/mm3
* Decompensated heart failure
* Hepatic failure Severe (TP\<50% or cytolysis severe (ALAT\> 3x ULN)
* Active TB during treatment with rifampicin
* Taking drugs that interact with the drugs of the clinical trial (as specified in the SPC)
* Pregnancy, breastfeeding or planning to become pregnant during study follow-up

Primary outcomes:
measure: The "overall success"
timeFrame: 96 weeks
Secondary outcomes:
measure: Therapeutic failure
timeFrame: 24 weeks
measure: Therapeutic failure
timeFrame: 48 weeks
measure: Incidence and type of severe clinical or biological severe adverse events per arm
timeFrame: between Week 0 and Week 96
measure: The clinical progression
timeFrame: between Week 0 and Week 96
measure: The evolution of CD4 counts
timeFrame: between Week 0 and Week 96
measure: The evolution of plasma HIV-2 RNA load
timeFrame: between at W0 and W96
measure: The observance of antiretroviral treatment
timeFrame: between W0 and W96
measure: The resistance mutations profile
timeFrame: Weeks 96
measure: The evolution of the HIV-2 DNA titers in PBMC
timeFrame: between Week 0 and Week 96
measure: The frequency of treatment switches and discontinuations
timeFrame: between Week 0 and Week 96
measure: To model the long-term survival and cost-effectiveness ratio
timeFrame: Weeks 96
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: CHU Sourô Sanou
city: Ouagadougou
country: Burkina Faso
facility: CHU Yalgado Ouedraogo
city: Abidjan
country: Côte D'Ivoire
facility: Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
city: Abidjan
country: Côte D'Ivoire
facility: Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre)
city: Abidjan
country: Côte D'Ivoire
facility: CIRBA
city: Abidjan
country: Côte D'Ivoire
facility: o L'Unité de soins ambulatoires et de conseils (USAC), CHU de Treichville
city: Abidjan
country: Côte D'Ivoire
facility: Service des Maladies Infectieuses et Tropicales (SMIT), CHU de treichville
city: Dakar
country: Senegal
facility: CHNU Fann
city: Lome
country: Togo
facility: ONG Espoirs Vie Togo (EVT)
Study officials:
affiliation: Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
name: Serge P. Eholié, MD, MSc, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratoire de virologie, Hôpital Bichat-Claude Bernard
name: Françoise P. Brun-Vézinet, MD, MSc, Pr
role: PRINCIPAL_INVESTIGATOR
References: