Randomised pilot trial to assess the efficacy and tolerability of Abacavir/Lamivudine treatment in patients with systemic lupus erythematosus (PENCIL)

Phase 1

Conditions: systemic lupus
MedDRA version: 21.1Level: PTClassification code: 10042945Term: Systemic lupus erythematosus Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-508611-22-00

Lead Sponsor: Hospices Civils De Lyon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Patient =12 years old (weighing more than 25 kg) and = 65 years old, Diagnosis of LS according to 2019 ACR (American College of rheumatology) / EULAR (European Ligue against Rheumatism) criteria (score >10), Patient with LS in remission or with low clinical activity according to LLDAS criteria, or female patients (including sexually active adolescents) of childbearing age, effective contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) for the entire duration of treatment is required. A pregnancy test will be carried out at inclusion., Patient affiliated to a social security scheme, Free, informed and written consent signed by the patient or his/her parents/legal guardian

Exclusion Criteria

History of allergy or hypersensitivity to Abacavir, lamivudine or the excipients (tablet core: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica, talc; film coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80), Patients with moderate or severe hepatic impairment (prothrombin level <50%), Patient taking part in other interventional research involving medicinal products, Patients on anti-retroviral treatment, Patients with chronic HIV, HBV or HCV infection, Pregnant or breast-feeding woman, Patient treated with Lamivudine and/or Abacavir, Patient treated with a cytidine analogue, Patient receiving treatment containing Cladribine, Patient receiving treatment containing a trimethoprim/sulphamethoxazole combination, Patients with renal impairment (creatinine clearance < 50 ml/min)