First-Line Treatment for HIV-2

• Status: Completed
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Emtricitabine; Lamivudine; Lamivudine, zidovudine drug combination; Lopinavir; Raltegravir Potassium; Ritonavir; Tenofovir; Zidovudine

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