Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
210 participants
INTERVENTIONAL
2016-01-26
2019-05-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
NCT01605890
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01533259
An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal
NCT02180438
Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé)
NCT00928187
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01475838
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A : TDF + FTC (or 3TC) + ZDV
Tenofovir + Emtricitabine or Lamivudine + Zidovudine
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)
TDF+FTC (or 3TC) +LPV/r
Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir
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)
Arm C : TDF +FTC (or 3TC) + RAL
Tenofovir + Emtricitabine or Lamivudine + Raltegravir
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
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)
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Serge P. Eholié, MD, MSc, Pr
Role: PRINCIPAL_INVESTIGATOR
Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
Françoise P. Brun-Vézinet, MD, MSc, Pr
Role: PRINCIPAL_INVESTIGATOR
Laboratoire de virologie, Hôpital Bichat-Claude Bernard
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Sourô Sanou
Bobo-Dioulasso, , Burkina Faso
CHU Yalgado Ouedraogo
Ouagadougou, , Burkina Faso
Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
Abidjan, , Côte d’Ivoire
Centre Médical du Suivi des Donneurs de Sang (Blood Bank Medical Centre)
Abidjan, , Côte d’Ivoire
CIRBA
Abidjan, , Côte d’Ivoire
o L'Unité de soins ambulatoires et de conseils (USAC), CHU de Treichville
Abidjan, , Côte d’Ivoire
Service des Maladies Infectieuses et Tropicales (SMIT), CHU de treichville
Abidjan, , Côte d’Ivoire
CHNU Fann
Dakar, , Senegal
ONG Espoirs Vie Togo (EVT)
Lomé, , Togo
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
sponsor site
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANRS 12294 FIT-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.