Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

November 1, 2028

Study Completion Date

June 1, 2029

Conditions
Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

Blood sample

"blood test to assess :~* human leukocyte antigen (HLA)-B\*5701 status to identify risk of allergy or hypersensitivity to abacavir (the study treatment)~* IFN-signature ans IFN-alpha dosage~* human immunodeficiency virus (HIV), hepatitis B virus (HBV) and Hepatitis C virus (HCV) serologies~* Human chorionic gonadotropin (βHCG)~* HERVs dosage A biological collection will also be created. The total volume of blood collected specifically for the research for the entire duration of the study is 62.5 millilitre (mL) maximum."

DRUG

Treatment :Abacavir 600 mg/lamivudine 300 mg

Patients randomised to the experimental arm will be required to take 1 tablet (600 mg lamivudine and 300 mg abacavir) once daily for 6 months in addition to their usual treatment.

OTHER

Lupus Impact Tracker questionnaire

Patients will be asked to complete the Lupus Impact Tracker questionnaire at visit V1 (randomisation visit), visit 3 (at 6 months of treatment) and visit 4 (12 months after visit 1).

Trial Locations (11)

33076

Groupe Hospitalier Pellegrin-CHU de Bordeaux, Bordeaux

38043

CHU Nord de Grenoble - Albert Michallon, Grenoble

42270

CHU de Saint-Etienne - Hôpital Nord, Saint-Priest-en-Jarez

59037

Hôpital Claude Huriez, Lille

63003

CHU de Clermont-Ferrand - Hôpital Gabriel Montpied, Clermont-Ferrand

69004

Hôpital de la Croix-Rousse (HCL), Lyon

69310

Hôpital Lyon Sud (HCL), Pierre-Bénite

69437

Hôpital Edouard Herriot (HCL), Lyon

69677

Hôpital Femme-Mère-Enfant (HCL), Bron

75015

Hôpital Necker-Enfants malades, Paris

75651

Hôpital Pitié-Salpêtrière, Paris

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT06356740 - Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter