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Completed

NCT Number: NCT02150993

First-Line Treatment for HIV-2

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.

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Key information

Conditions

HIV-2 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Sourô Sanou, Bobo-Dioulasso, Burkina Faso

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: TDF+FTC (or 3TC) + ZDV, TDF+FTC (or 3TC) + AZT

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)

Other names: 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)

Other names: TDF +FTC (or 3TC) + RAL

Primary outcomes

  1. 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 outcomes

  1. Therapeutic failure

    Time frame: 24 weeks

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

    • death or
    • 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
    • a plasma HIV-2 RNA viral load of > or =50 copies/ml or
    • the occurrence of an AIDS defining event (excluding tuberculosis).

  2. Therapeutic failure

    Time frame: 48 weeks

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

    • death or
    • 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
    • a plasma HIV-2 RNA viral load of > or = 50 copies/ml or
    • the occurrence of an AIDS defining event (excluding tuberculosis).

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

    Time frame: between Week 0 and Week 96

    Incidence and type of severe clinical or biological severe adverse event (grade 3 or 4)

  4. 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

  5. The evolution of CD4 counts

    Time frame: between Week 0 and Week 96

    Evolution of the absolute and percentage CD4 counts during follow-up

  6. The evolution of plasma HIV-2 RNA load

    Time frame: between at W0 and W96

    Evolution of the plasma viral load during follow-up

  7. The observance of antiretroviral treatment

    Time frame: between W0 and W96

    To describe the antiretroviral possession ratio and assessment of compliance by questionnaire

  8. The resistance mutations profile

    Time frame: Weeks 96

    Description of new resistance mutations profiles in cases of treatment failure

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study 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

Acronym: FIT-2

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 30, 2014
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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