First-Line Treatment for HIV-2

NCT02150993 | Completed Phase 2 DMC

• 1 other identifier: ANRS 12294 FIT-2
• Study Type: interventional
• Target: 210
• Locations: 4 countries
• Sites: 9

Brief 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.

Conditions

HIV-2 Infection

Keywords

Africa; Antiretroviral Treatment; HIV-2; firsts line ART; Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  96 weeks

Secondary Outcomes (11)

• Therapeutic failure

  24 weeks

• Therapeutic failure

  48 weeks

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

  between Week 0 and Week 96

• The clinical progression

  between Week 0 and Week 96

• The evolution of CD4 counts

  between Week 0 and Week 96

Study Arms (3)

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

EXPERIMENTAL

Tenofovir + Emtricitabine or Lamivudine + Zidovudine

Drug: Tenofovir + Emtricitabine or Lamivudine + Zidovudine

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

EXPERIMENTAL

Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir

Drug: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir

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

EXPERIMENTAL

Tenofovir + Emtricitabine or Lamivudine + Raltegravir

Drug: Tenofovir + Emtricitabine or Lamivudine + Raltegravir

Interventions

Tenofovir + Emtricitabine or Lamivudine + Zidovudine DRUG

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)

Also known as: TDF+FTC (or 3TC) + ZDV, TDF+FTC (or 3TC) + AZT

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

Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir DRUG

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)

Also known as: TDF +FTC (or 3TC) +LPV/r

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

Tenofovir + Emtricitabine or Lamivudine + Raltegravir DRUG

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)

Also known as: TDF +FTC (or 3TC) + RAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (9)

CHU Sourô Sanou

Bobo-Dioulasso, Burkina Faso

Location

CHU Yalgado Ouedraogo

Ouagadougou, Burkina Faso

Location

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

Abidjan, Côte d’Ivoire

Location

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

Abidjan, Côte d’Ivoire

Location

CIRBA

Abidjan, Côte d’Ivoire

Location

o L'Unité de soins ambulatoires et de conseils (USAC), CHU de Treichville

Abidjan, Côte d’Ivoire

Location

Service des Maladies Infectieuses et Tropicales (SMIT), CHU de treichville

Abidjan, Côte d’Ivoire

Location

CHNU Fann

Dakar, Senegal

Location

ONG Espoirs Vie Togo (EVT)

Lomé, Togo

Location

Related Publications (1)

• 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.

  PMID: 38740027 DERIVED

Related Links

• sponsor site
• Related Info

MeSH Terms

Interventions

Tenofovir; Emtricitabine; Lamivudine; Zidovudine; Lopinavir; Ritonavir; Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Dideoxynucleosides; Thymidine; Pyrimidinones; Thiazoles; Sulfur Compounds; Azoles; Pyrrolidinones; Pyrrolidines

Study Officials

• Serge P. Eholié, MD, MSc, Pr

  Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire

  PRINCIPAL INVESTIGATOR

• Françoise P. Brun-Vézinet, MD, MSc, Pr

  Laboratoire de virologie, Hôpital Bichat-Claude Bernard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: January 26, 2016
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

BU (2); TO (1); SE (1); CÔ (5)