First-Line Treatment for HIV-2

Phase 2/3 Completed 210 enrolled ANRS, Emerging Infectious Diseases

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2016-01-26
Primary completion: 2019-05-15
Completion: 2019-05-15

Publications

Eholie SP, Ekouevi DK, Chazallon C, Charpentier C, Messou E, Diallo Z, Zoungrana J, Minga A, Ngom Gueye NF, Hawerlander D, Dembele F, Colin G, Tchounga B, Karcher S, Le Carrou J, Tchabert-Guie A, Toni TD, Ouedraogo AS, Bado G, Toure Kane C, Seydi M, Poda A, Mensah E, Diallo I, Drabo YJ, Anglaret X, Brun-Vezinet F; FIT-2 study group. Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial. Lancet HIV. 2024 Jun;11(6):e380-e388. doi: 10.1016/S2352-3018(24)00085-7. Epub 2024 May 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lamivudine	Other / unclassified	300 mg	Oral
Subject	Lopinavir	Other / unclassified	400 mg	Oral
Subject	Raltegravir	Other / unclassified	400 mg	Oral
Subject	Ritonavir	Other / unclassified	100 mg	Oral
Subject	Tenofovir disoproxil fumarate	Small molecule	245 mg	Oral
Subject	Zidovudine	Small molecule	300 mg	Oral
Subject	emtricitabine	Other / unclassified	200 mg	Oral

Indications

No indication recorded.