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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
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)
ClinicalTrials.gov Identifier:
NCT02150993
First received: May 28, 2014
Last updated: May 29, 2014
Last verified: May 2014
  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, Guinea).

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

    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 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> 50 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 ] [ Designated as safety issue: No ]

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

    1. death or
    2. a delta CD4 ≤0 cells/mm3 or
    3. a plasma HIV-2 RNA viral load of >50 copies/ml or
    4. the occurrence of an AIDS defining event (excluding tuberculosis).

  • Therapeutic failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

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

    1. death or
    2. a delta CD4 ≤0 cells/mm3 between or
    3. a plasma HIV-2 RNA viral load of >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 ] [ Designated as safety issue: Yes ]
  • The clinical progression [ Time Frame: between Week 0 and Week 96 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evolution of the plasma viral load during follow-up

  • The observance of antiretroviral treatment [ Time Frame: between W0 and W96 ] [ Designated as safety issue: No ]
    To describe the antiretroviral possession ratio and assessment of compliance by questionnaire

  • The resistance mutations profile [ Time Frame: Weeks 96 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The frequency of modifications and discontinuations of treatment per arm

  • To model the long-term survival and cost-effectiveness ratio [ Time Frame: Weeks 96 ] [ Designated as safety issue: No ]
    The probability of survival and the incremental cost-effectiveness of these three treatment regimens


Estimated Enrollment: 210
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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 between 200 and 600 cells/mm3 or with HIV-2 RNA viral loads >50copies/ml and 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 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> 50 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)
  • CD4 >200/mm3 and ≤600/mm3 irrespective of plasma HIV-2 RNA viral load, OR HIV-2 RNA viral load plasma > 50 copies/ml if the CD4 count is >200 cells/mm3
  • Resident of the city where the study is held or of city suburbs to facilitate participation
  • Signed informed consent
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infection by HIV-2 only;
  • Age > 18 years;
  • Naïve for antiretroviral therapy (including antiretroviral treatment in the context of PMTCT)
  • CD4 >200/mm3 and ≤600/mm3 irrespective of plasma HIV-2 RNA viral load, OR HIV-2 RNA viral load plasma > 50 copies/ml if the CD4 count is >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 / L
  • Neutrophil count <500 cells/mm3
  • Renal impairment with creatinine clearance <50mL/mn
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02150993

Contacts
Contact: Géraldine Colin, DPharm +22521755960 geraldine.colin11@gmail.com
Contact: Xavier Anglaret, MD, PHD +22521755960 Xavier.Anglaret@isped.u-bordeaux2.fr

Locations
Burkina Faso
CHU Sourô Sanou Not yet recruiting
Bobo-Dioulasso, Burkina Faso
Contact: Adrien B Sawadogo, MD    +22620985255    sawadogoadrien@yahoo.fr   
Contact: Jacques Zougrana, MD    +22620983758    zojacques@yahoo.fr   
Sub-Investigator: Jacques Zoungrana, MD         
CHU Yalgado Ouedraogo Not yet recruiting
Ouagadougou, Burkina Faso
Contact: Youssef Joseph Drabo, Pr. MD    +22650311656    yjdrabo@yahoo.fr   
Contact: Ismael Diallo, MD    +22670249814    illah_diallo@hotmail.com   
Principal Investigator: Isamel Diallo, MD         
Côte D'Ivoire
Centre de Prise en Charge et de Formation (CePReF), Association ACONDA Not yet recruiting
Abidjan, Côte D'Ivoire
Contact: Eugène Messou, MD, PhD    +22523462551    messou_eugene@yahoo.fr   
Contact: , MD         
Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre) Not yet recruiting
Abidjan, Côte D'Ivoire
Contact: Albert Kla Minga, MD, PhD    +225 21 35 52 78    minga.albert@yahoo.fr   
Service des Maladies Infectieuses et Tropicales (SMIT) Not yet recruiting
Abidjan, Côte D'Ivoire
Contact: Emmanuel Bissagnene, MD, Pr    +22521755960    bissagnene@yahoo.fr   
Contact: , MD         
Sub-Investigator: Eboumou Gole, MD         
CIRBA Not yet recruiting
Abidjan, Côte D'Ivoire
Contact: Henry Chenal, MD       chenalhenri@gmail.com   
Contact: Denise Hawerlander, MD    +225 07 67 25 59    hawer_d@yahoo.fr   
Sub-Investigator: Denise Hawerlander, MD         
Senegal
CHNU Fann Not yet recruiting
Dakar, Senegal
Contact: Moussa Seydi, MD, Pr    +221338231327    seydi_moussa@gmail.com   
Contact: Nogaye Gaye    +221338698193    nogayegaye@hotmail.com   
Hopital du district de Ziguinchor Not yet recruiting
Ziguinchor, Senegal
Contact: Noël Magloire Manga, MD    +221338647553    noelmagloiremanga@yahoo.fr   
Togo
CHU Sylvanus-Olympio Not yet recruiting
Lomé, Togo
Contact: Patassi Akouda, MD    +228 90 98 17 74    patassi40@yahoo.fr   
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:
No publications provided

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
Study First Received: May 28, 2014
Last Updated: May 29, 2014
Health Authority: Burkina Faso: Ministry of Health
Burkina Faso: Ministère de la Recherche Scientifique et de l'Innovation
Burkina Faso: Comité d'Ethique pour la Recherche en Santé
Cote d'Ivoire: Ministère de la Santé et de la Lutte contre le SIDA
Cote d'Ivoire: Comité National d'Ethique et de la Recherche
Senegal: Ministere de la Sante et de l'Action Sociale
Senegal: Comité National d'Ethique pour la Recherche en Santé
Guinee Conakry: Ministère de la Santé et de l'Hygiène Publique (MSHP)
Guinee Conakry: Comité national d'éthique pour la recherche en santé (CNERS)
Togo : Comité de bioéthique pour la recherche en santé ( CBRS)
Togo : ministère de la santé

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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Zidovudine
Lamivudine
Tenofovir
Tenofovir disoproxil
Lamivudine, zidovudine drug combination
Ritonavir
Lopinavir
Emtricitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014