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First-Line Treatment for HIV-2 (FIT-2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02150993
First Posted: May 30, 2014
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  Purpose

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.


Condition Intervention Phase
HIV-2 Infection Drug: Tenofovir + Emtricitabine or Lamivudine + Zidovudine Drug: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir Drug: Tenofovir + Emtricitabine or Lamivudine + Raltegravir Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • The "overall success" [ Time Frame: 96 weeks ]

    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.



Secondary Outcome Measures:
  • Therapeutic failure [ Time Frame: 24 weeks ]

    The percentage of patients in "treatment failure" defined by :

    1. death or
    2. a delta ≤0 CD4 cells / mm3 between W2 and W24 (or W48) for patients with baseline CD4 between 201 and 500 cells / mm3 or if % of decrease in CD4 > 20% between W2 and W24 (or W48) for patients with baseline CD4 > 500 cellules/mm3 or
    3. a plasma HIV-2 RNA viral load of > or =50 copies/ml or
    4. the occurrence of an AIDS defining event (excluding tuberculosis).

  • Therapeutic failure [ Time Frame: 48 weeks ]

    The percentage of patients in "treatment failure" defined by :

    1. death or
    2. a delta ≤0 CD4 cells / mm3 between W2 and W24 (or W48) for patients with baseline CD4 between 201 and 500 cells / mm3 or if % of decrease in CD4 > 20% between W0 and W24 (or W48) for patients with baseline CD4 > 500 cellules/mm3 or
    3. a plasma HIV-2 RNA viral load of > or = 50 copies/ml or
    4. the occurrence of an AIDS defining event (excluding tuberculosis).

  • Incidence and type of severe clinical or biological severe adverse events (grade 3 or 4 on the ANRS grading table) per arm [ Time Frame: between Week 0 and Week 96 ]
  • The clinical progression [ Time Frame: between Week 0 and Week 96 ]
    The incidence of severe morbidity, defined as: AIDS morbidity, non-AIDS cancer, severe non-AIDS bacterial disease, or any disease leading to death

  • The evolution of CD4 counts [ Time Frame: between Week 0 and Week 96 ]
    Evolution of the absolute and percentage CD4 counts during follow-up

  • The evolution of plasma HIV-2 RNA load [ Time Frame: between at W0 and W96 ]
    Evolution of the plasma viral load during follow-up

  • The observance of antiretroviral treatment [ Time Frame: between W0 and W96 ]
    To describe the antiretroviral possession ratio and assessment of compliance by questionnaire

  • The resistance mutations profile [ Time Frame: Weeks 96 ]
    Description of new resistance mutations profiles in cases of treatment failure

  • The evolution of the HIV-2 DNA titers in PBMC [ Time Frame: between Week 0 and Week 96 ]
    To describe the evolution the HIV-2 DNA titers in PBMC

  • The frequency of treatment switches and discontinuations [ Time Frame: between Week 0 and Week 96 ]
    The frequency of modifications and discontinuations of treatment per arm

  • To model the long-term survival and cost-effectiveness ratio [ Time Frame: Weeks 96 ]
    The probability of survival and the incremental cost-effectiveness of these three treatment regimens


Enrollment: 210
Actual Study Start Date: January 26, 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A : TDF + FTC (or 3TC) + ZDV
Tenofovir + Emtricitabine or Lamivudine + Zidovudine
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)
Other Names:
  • TDF+FTC (or 3TC) + ZDV
  • TDF+FTC (or 3TC) + AZT
Experimental: TDF+FTC (or 3TC) +LPV/r
Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir
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)
Other Name: TDF +FTC (or 3TC) +LPV/r
Experimental: Arm C : TDF +FTC (or 3TC) + RAL
Tenofovir + Emtricitabine or Lamivudine + Raltegravir
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)
Other Name: TDF +FTC (or 3TC) + RAL

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150993


Locations
Burkina Faso
CHU Sourô Sanou
Bobo-Dioulasso, Burkina Faso
CHU Yalgado Ouedraogo
Ouagadougou, Burkina Faso
Côte D'Ivoire
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
Senegal
CHNU Fann
Dakar, Senegal
Togo
ONG Espoirs Vie Togo (EVT)
Lome, Togo
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02150993     History of Changes
Other Study ID Numbers: ANRS 12294 FIT-2
First Submitted: May 28, 2014
First Posted: May 30, 2014
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Africa
Antiretroviral Treatment
HIV-2
firsts line ART
Adults

Additional relevant MeSH terms:
Ritonavir
Lopinavir
Tenofovir
Lamivudine
Raltegravir Potassium
Emtricitabine
Zidovudine
Lamivudine, zidovudine drug combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Antimetabolites