First-Line Treatment for HIV-2 (FIT-2)

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 3; Phase 2

Conditions: HIV-2 Infection

Treatments: Drug: Tenofovir + Emtricitabine or Lamivudine + Raltegravir; Drug: Tenofovir + Emtricitabine or Lamivudine + Zidovudine; Drug: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT02150993

ANRS 12294 FIT-2

Details and patient eligibility

About

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.

Full 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

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Arm A : TDF + FTC (or 3TC) + ZDV

Experimental group

Description:

Tenofovir + Emtricitabine or Lamivudine + Zidovudine

Treatment:

Drug: Tenofovir + Emtricitabine or Lamivudine + Zidovudine

TDF+FTC (or 3TC) +LPV/r

Experimental group

Description:

Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir

Treatment:

Drug: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir

Arm C : TDF +FTC (or 3TC) + RAL

Experimental group

Description:

Tenofovir + Emtricitabine or Lamivudine + Raltegravir

Treatment:

Drug: Tenofovir + Emtricitabine or Lamivudine + Raltegravir