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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : TDF + FTC (or 3TC) + ZDV | Experimental | Tenofovir + Emtricitabine or Lamivudine + Zidovudine |
|
| TDF+FTC (or 3TC) +LPV/r | Experimental | Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir |
|
| Arm C : TDF +FTC (or 3TC) + RAL | Experimental | Tenofovir + Emtricitabine or Lamivudine + Raltegravir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic failure | The percentage of patients in "treatment failure" defined by :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sourô Sanou | Bobo-Dioulasso | Burkina Faso | ||||
| CHU Yalgado Ouedraogo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38740027 | Derived | 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. |
| Label | URL |
|---|---|
| sponsor site | View source |
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|
| 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) |
|
|
| 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) |
|
|
| 24 weeks |
| Therapeutic failure | The percentage of patients in "treatment failure" defined by :
| 48 weeks |
| Incidence and type of severe clinical or biological severe adverse events per arm | Incidence and type of severe clinical or biological severe adverse event (grade 3 or 4) | between Week 0 and Week 96 |
| The clinical progression | The incidence of severe morbidity, defined as: AIDS morbidity, non-AIDS cancer, severe non-AIDS bacterial disease, or any disease leading to death | between Week 0 and Week 96 |
| The evolution of CD4 counts | Evolution of the absolute and percentage CD4 counts during follow-up | between Week 0 and Week 96 |
| The evolution of plasma HIV-2 RNA load | Evolution of the plasma viral load during follow-up | between at W0 and W96 |
| The observance of antiretroviral treatment | To describe the antiretroviral possession ratio and assessment of compliance by questionnaire | between W0 and W96 |
| The resistance mutations profile | Description of new resistance mutations profiles in cases of treatment failure | Weeks 96 |
| The evolution of the HIV-2 DNA titers in PBMC | To describe the evolution the HIV-2 DNA titers in PBMC | between Week 0 and Week 96 |
| The frequency of treatment switches and discontinuations | The frequency of modifications and discontinuations of treatment per arm | between Week 0 and Week 96 |
| To model the long-term survival and cost-effectiveness ratio | The probability of survival and the incremental cost-effectiveness of these three treatment regimens | Weeks 96 |
| Ouagadougou |
| Burkina Faso |
| Centre de Prise en Charge et de Formation (CePReF), Association ACONDA | Abidjan | Côte d’Ivoire |
| Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre) | Abidjan | Côte d’Ivoire |
| CIRBA | Abidjan | Côte d’Ivoire |
| o L'Unité de soins ambulatoires et de conseils (USAC), CHU de Treichville | Abidjan | Côte d’Ivoire |
| Service des Maladies Infectieuses et Tropicales (SMIT), CHU de treichville | Abidjan | Côte d’Ivoire |
| CHNU Fann | Dakar | Senegal |
| ONG Espoirs Vie Togo (EVT) | Lomé | Togo |
| Related Info | View source |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D019259 | Lamivudine |
| D015215 | Zidovudine |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D016047 | Zalcitabine |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
| D011744 | Pyrimidinones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
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