First-Line Treatment for HIV-2

ANRS, Emerging Infectious Diseases210 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

HIV-2 Infection

Interventions

Tenofovir + Emtricitabine or Lamivudine + ZidovudineDRUG

TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + ZDV (Zidovudine 300 mg) 1 tb BID (mornings and evenings orally)

Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavirDRUG

TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + Lop/r (Lopinavir/ritonavir lopinavir 200/50 mg) 2 tbs BID (mornings and evenings orally)

Tenofovir + Emtricitabine or Lamivudine + RaltegravirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

CHU Sourô Sanou

Bobo-Dioulasso, Burkina Faso

CHU Yalgado Ouedraogo

Ouagadougou, Burkina Faso

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

Abidjan, Côte d’Ivoire

Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre)

Outcomes

Primary Outcomes

The "overall success"

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) A treatment is considered to be effective if the "global success" is \> 55 % at 96 weeks.

Time frame: 96 weeks

Secondary Outcomes

Therapeutic failure

The percentage of patients in "treatment failure" defined by : 1. death or 2. a delta ≤0 CD4 cells / mm3 between W2 and W24 (or W48) for patients with baseline CD4 between 201 and 500 cells / mm3 or if % of decrease in CD4 \> 20% between W2 and W24 (or W48) for patients with baseline CD4 \> 500 cellules/mm3 or 3. a plasma HIV-2 RNA viral load of \> or =50 copies/ml or 4. the occurrence of an AIDS defining event (excluding tuberculosis).

Time frame: 24 weeks

Therapeutic failure

The percentage of patients in "treatment failure" defined by : 1. death or 2. a delta ≤0 CD4 cells / mm3 between W2 and W24 (or W48) for patients with baseline CD4 between 201 and 500 cells / mm3 or if % of decrease in CD4 \> 20% between W0 and W24 (or W48) for patients with baseline CD4 \> 500 cellules/mm3 or 3. a plasma HIV-2 RNA viral load of \> or = 50 copies/ml or 4. the occurrence of an AIDS defining event (excluding tuberculosis).

Time frame: 48 weeks

Incidence and type of severe clinical or biological severe adverse events per arm

Incidence and type of severe clinical or biological severe adverse event (grade 3 or 4)

Time frame: between Week 0 and Week 96

Data from ClinicalTrials.gov

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