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Randomised, controlled phase II proof-of-concept trial to assess the efficacy of abaCavIr/lamivudine treatment on the interferon signature in patients with systemic lupus erythematosus - PENCIL
EU CTIS ID: 2023-508611-22-00
What this study is testing
To compare the addition of the Abacavir/Lamivudine combination (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptome signature of patients with systemic lupus with low activity as defined by the LLDAS (Lupus Low Disease Activity State), in the 2 treatment arms, on the total population, on the paediatric population and on the adult population.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 (Bactrim)
- Patients with renal impairment (creatinine clearance < 50 ml/min)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.