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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02150993 |
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Date of registration:
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28/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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First-Line Treatment for HIV-2
FIT-2 |
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Scientific title:
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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 |
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Date of first enrolment:
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January 26, 2016 |
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Target sample size:
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210 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02150993 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Burkina Faso
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Côte D'Ivoire
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Senegal
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Togo
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Contacts
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Name:
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Françoise P. Brun-Vézinet, MD, MSc, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Laboratoire de virologie, Hôpital Bichat-Claude Bernard |
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Name:
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Serge P. Eholié, MD, MSc, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV-2 Infection
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Intervention(s)
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Drug: Tenofovir + Emtricitabine or Lamivudine + Raltegravir
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Drug: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir
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Drug: Tenofovir + Emtricitabine or Lamivudine + Zidovudine
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Primary Outcome(s)
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The "overall success"
[Time Frame: 96 weeks]
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Secondary Outcome(s)
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The evolution of the HIV-2 DNA titers in PBMC
[Time Frame: between Week 0 and Week 96]
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To model the long-term survival and cost-effectiveness ratio
[Time Frame: Weeks 96]
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The evolution of plasma HIV-2 RNA load
[Time Frame: between at W0 and W96]
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The frequency of treatment switches and discontinuations
[Time Frame: between Week 0 and Week 96]
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The resistance mutations profile
[Time Frame: Weeks 96]
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Incidence and type of severe clinical or biological severe adverse events per arm
[Time Frame: between Week 0 and Week 96]
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The clinical progression
[Time Frame: between Week 0 and Week 96]
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The evolution of CD4 counts
[Time Frame: between Week 0 and Week 96]
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The observance of antiretroviral treatment
[Time Frame: between W0 and W96]
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Therapeutic failure
[Time Frame: 48 weeks]
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Therapeutic failure
[Time Frame: 24 weeks]
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Secondary ID(s)
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ANRS 12294 FIT-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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