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HIV-2 InfectionPhase 2/3FIT-2NCT02150993

First-Line Treatment for HIV-2

A Phase 2/3 study testing Tenofovir + Emtricitabine or Lamivudine + Zidovudine, Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir and Tenofovir + Emtricitabine or Lamivudine + Raltegravir in people with HIV-2 Infection, run by ANRS, Emerging Infectious Diseases at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-2 Infection
What is being tested?
Tenofovir + Emtricitabine or Lamivudine + Zidovudine, Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir and Tenofovir + Emtricitabine or Lamivudine + Raltegravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
9 sitesin 4 countries
Study dates
26 Jan 2016to 15 May 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

Côte d’Ivoire5 sites

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

    Abidjan

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

    Abidjan

  • CIRBA

    Abidjan

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

    Abidjan

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

    Abidjan

Other trials in Côte d’Ivoire

Burkina Faso2 sites

  • CHU Sourô Sanou

    Bobo-Dioulasso

  • CHU Yalgado Ouedraogo

    Ouagadougou

Other trials in Burkina Faso

Senegal1 site

  • CHNU Fann

    Dakar

Other trials in Senegal

Togo1 site

  • ONG Espoirs Vie Togo (EVT)

    Lomé

About this study

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

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.

Read the 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
Conditions
HIV-2 Infection
Being tested
Tenofovir + Emtricitabine or Lamivudine + Zidovudine, Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir, Tenofovir + Emtricitabine or Lamivudine + Raltegravir
Keywords
Africa, Antiretroviral Treatment, HIV-2, firsts line ART, Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenofovir + Emtricitabine or Lamivudine + ZidovudineDrug

    Also called TDF+FTC (or 3TC) + ZDV, TDF+FTC (or 3TC) + AZT

    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)

  • Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavirDrug

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

    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 + RaltegravirDrug

    Also called TDF +FTC (or 3TC) + RAL

    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)

Study groups in NCT02150993
Study groupRoleWhat they receive
Arm A : TDF + FTC (or 3TC) + ZDVExperimentalTenofovir + Emtricitabine or Lamivudine + Zidovudine
Receives: Drug: Tenofovir + Emtricitabine or Lamivudine + Zidovudine
TDF+FTC (or 3TC) +LPV/rExperimentalTenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir
Receives: Drug: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir
Arm C : TDF +FTC (or 3TC) + RALExperimentalTenofovir + Emtricitabine or Lamivudine + Raltegravir
Receives: Drug: Tenofovir + Emtricitabine or Lamivudine + Raltegravir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 96 weeks

Secondary outcomes (11)

  1. Therapeutic failure

    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).

    Measured: 24 weeks

  2. Therapeutic failure

    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).

    Measured: 48 weeks

  3. 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)

    Measured: between Week 0 and Week 96

  4. 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

    Measured: between Week 0 and Week 96

  5. The evolution of CD4 counts

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

    Measured: between Week 0 and Week 96

  6. The evolution of plasma HIV-2 RNA load

    Evolution of the plasma viral load during follow-up

    Measured: between at W0 and W96

  7. The observance of antiretroviral treatment

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

    Measured: between W0 and W96

  8. The resistance mutations profile

    Description of new resistance mutations profiles in cases of treatment failure

    Measured: Weeks 96

  9. The evolution of the HIV-2 DNA titers in PBMC

    To describe the evolution the HIV-2 DNA titers in PBMC

    Measured: between Week 0 and Week 96

  10. The frequency of treatment switches and discontinuations

    The frequency of modifications and discontinuations of treatment per arm

    Measured: between Week 0 and Week 96

  11. To model the long-term survival and cost-effectiveness ratio

    The probability of survival and the incremental cost-effectiveness of these three treatment regimens

    Measured: Weeks 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2014 (estimated)
  2. Study start26 Jan 2016
  3. Primary completion15 May 2019
  4. Study completion15 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02150993
Sponsor's protocol ID
ANRS 12294 FIT-2
Acronym
FIT-2
Status last verified
Jul 2019
First submitted
28 May 2014
Last updated
22 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38740027

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tenofovir + Emtricitabine or Lamivudine + Zidovudine, Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir and Tenofovir + Emtricitabine or Lamivudine + Raltegravir in people with HIV-2 Infection, run by ANRS, Emerging Infectious Diseases at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Côte d’Ivoire, Burkina Faso, Senegal, Togo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The "overall success" (time frame: 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02150993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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