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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2029-06-01

Brief Summary

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Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). IFN-α production results from the excessive detection of nucleic acids (DNA or Ribonucleic Acid (RNA)) by endosomal or intracytoplasmic receptors that are capable of inducing interferon production. The precise mechanisms of cytoplasmic sensor activation remain unknown; however, recent work in the field of interferonopathies suggests a role for human endogenous retroviruses (HERVs). HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8% of the human genome.Several studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons (I IFN) signalling pathway.

To date, none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus (SLE) have been shown to be effective in the background treatment of SL or in preventing relapse. Consequently, there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies.

In this study, an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors (NRTIs), abacavir/lamivudine, is proposed to treat SLE. Thus, we propose a pilot Phase II, randomized, open-label study using NRTIs in patients with SL in remission or with low clinical activity, and evaluating a biological endpoint (IFN signature), which is a direct proxy for the drug's expected effect.

The main objective is to compare the addition of Abacavir/Lamivudine (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State (LLDAS).

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label randomized, controlled study with 2 parallel arms (Add-on treatment versus standard of care treatment)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abacavir 600 mg/lamivudine 300 mg

Patients randomized to this group will take 1 tablet (600 mg lamivudine and 300 mg abacavir) once daily for 6 months in addition to their usual treatment.

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

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.

Treatment :Abacavir 600 mg/lamivudine 300 mg

Intervention Type DRUG

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.

Lupus Impact Tracker questionnaire

Intervention Type OTHER

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).

Control group (standard of care)

Patients randomized to this group will continue their usual treatment for lupus systemic.

Group Type ACTIVE_COMPARATOR

Blood sample

Intervention Type BIOLOGICAL

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.

Lupus Impact Tracker questionnaire

Intervention Type OTHER

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).

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

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).

Intervention Type OTHER

Eligibility Criteria

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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
* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No