NCT02150993

First-Line Treatment for HIV-2

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV-2 Infection

Interventions

Type	Name	Description
DRUG	Tenofovir + Emtricitabine or Lamivudine + Zidovudine	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)
DRUG	Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir	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)
DRUG	Tenofovir + Emtricitabine or Lamivudine + Raltegravir	TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + RAL (Raltegravir 400 mg) 1 tb BID (mornings and evenings orally)

Timeline

• Start date: 2016-01-26
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2014-05-30
• Last updated: 2019-07-22

Locations

9 sites across 4 countries: Burkina Faso, Côte d’Ivoire, Senegal, Togo