Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT02150993
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-Line Treatment for HIV-2
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIT-2
Brief 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.
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.
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: