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

Launched by HOSPICES CIVILS DE LYON · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication combination called Abacavir and Lamivudine in patients with systemic lupus erythematosus (SLE), a chronic disease where the immune system attacks the body. The researchers want to see if adding these medications to the usual treatment can help reduce certain markers in the blood that indicate disease activity. This study is particularly focused on patients who are in remission or have low disease activity, which means their symptoms are not very severe.

To participate in this trial, individuals must be between 12 and 65 years old, have a confirmed diagnosis of SLE, and be in a stable state of their condition. They should also be using effective contraception if they are capable of becoming pregnant. Participants will receive the Abacavir and Lamivudine for six months alongside their standard care and will be monitored for any changes in their health. It’s important to note that certain people, such as those with specific allergies or other health conditions, may not be eligible to join. If you or someone you know is interested in this study, please consult with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥12 years old (weighing more than 25 kg) and ≤ 65 years old
• • Diagnosis of SL according to 2019 American College of rheumatology (ACR) / European Ligue against Rheumatism (EULAR) criteria (score \>10)
• • Patient with SL in remission or with low clinical activity according to LLDAS disease criteria
• • For patients (including sexually active adolescents) of childbearing age, effective contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm, sponge with spermicide, or condom) for the entire duration of treatment is required. Pregnancy tests will be performed according to the inclusion criteria.
• • Patient affiliated to a social security scheme
• • Free, informed and written consent signed by patient or parents/legal guardian
• Exclusion Criteria:
• • Patients with HLA-B\*5701 status (risk of allergy or hypersensitivity to Abacavir)
• • History of allergy or hypersensitivity to abacavir, lamivudine, or excipients (tablet core: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica, talc; film coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80).
• • Patients on anti-retroviral therapy
• • 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 analog
• • Patient on treatment containing Cladribine
• • Patient on treatment containing a trimethoprim/sulfamethoxazole combination
• • Patients with renal insufficiency (creatinine clearance \< 50 ml/min)
• • Patients with moderate or severe hepatic impairment (prothrombin level \<50%)
• • Patient participating in other interventional drug research