RecruitingRare disease

Study on the Effects of Abacavir and Lamivudine in Patients with Systemic Lupus Erythematosus with Low Disease Activity

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Systemic Lupus Erythematosus, commonly known as lupus. Lupus is an autoimmune disease where the body's immune system mistakenly attacks healthy tissues. The treatment being tested is a combination of two medications, Abacavir and Lamivudine, which are typically used to treat viral infections. In this study, they are being used to see if they can help manage lupus by affecting certain immune system signals known as the interferon signature.

The purpose of the study is to evaluate how well the Abacavir/Lamivudine combination works when added to the standard care for lupus over a period of six months. Participants will be randomly assigned to receive either the medication combination or a placebo, in addition to their usual treatment. The study will monitor changes in the interferon signature, which is a pattern of gene activity linked to lupus, to see if the treatment can reduce it. The study will also look at other factors, such as the maintenance of low disease activity, the number of lupus relapses, and the use of other medications like corticosteroids.

Participants in the study will take the medication orally in the form of film-coated tablets. The trial will last for a total of six months, during which time the participants' health and response to the treatment will be closely monitored. The study aims to provide new insights into the potential benefits of using Abacavir and Lamivudine for treating lupus, which could lead to improved management of the disease in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis, and disease activity level.
A pregnancy test is conducted for female patients of childbearing age, and effective contraception is required throughout the treatment duration.
Step 2
Treatment initiation
The treatment involves taking a combination of abacavir and lamivudine in the form of film-coated tablets.
The medication is administered orally, with a dosage of 600 mg of abacavir and 300 mg of lamivudine.
Step 3
Treatment duration
The treatment is administered for a period of 6 months.
The primary goal is to assess changes in the interferon signature, which is a measure of certain gene expressions related to the immune system.
Step 4
Monitoring and assessment
Throughout the trial, the maintenance of low disease activity or remission is evaluated.
Regular assessments include monitoring lupus biomarkers and the cumulative dose of corticosteroids.
Step 5
Completion of treatment
After 6 months, the primary endpoint is the change in the interferon signature.
Secondary endpoints include the percentage of patients maintaining low disease activity, the number of relapses, and treatment adherence.
Step 6
Extended monitoring
Monitoring continues up to 12 months to assess long-term outcomes such as relapse rates and changes in lupus impact scores.
Adverse events and serious adverse events are recorded throughout the trial duration.

Who can join the trial?

6 criteria

Patient must be between 12 and 65 years old and weigh more than 25 kg (about 55 pounds).
Patient must have a diagnosis of **systemic lupus** according to specific criteria set by the American College of Rheumatology and the European League Against Rheumatism, with a score greater than 10.
Patient must have **systemic lupus** that is either in remission (inactive) or has low clinical activity, as defined by the LLDAS criteria.
Female patients of childbearing age, including sexually active adolescents, must use effective contraception throughout the treatment. This can include methods like sexual abstinence, hormonal contraception, an intrauterine device, a hormone-releasing system, or barrier methods like a cap, diaphragm, or sponge with spermicide, or a condom. A pregnancy test will be conducted at the start of the study.
Patient must be affiliated with a social security scheme.
Patient or their parents/legal guardian must provide free, informed, and written consent to participate in the study.

Who cannot join the trial?

6 criteria

Patients who do not have systemic lupus cannot participate. Systemic lupus is a condition where the body's defense system attacks its own tissues.
Patients with high disease activity, meaning their lupus symptoms are not well controlled, are excluded.
Patients who are not in the Lupus Low Disease Activity State (LLDAS) cannot join. LLDAS means the lupus symptoms are mild and stable.
Patients who are not within the specified age range for the study are excluded. The study includes children, teenagers, and adults.
Both male and female patients can participate, but those who do not meet other criteria are excluded.
Patients who are considered part of a vulnerable population, meaning they might need special protection or care, are excluded.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU Grenoble Alpes
Verified
La Tronche, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Centre Hospitalier Universitaire De Bordeaux
Verified
Bordeaux, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Abacavir
is a medication used in this trial to help manage systemic lupus erythematosus. It is being tested to see if it can affect the interferon signature, which is a marker related to the disease. Abacavir is usually used to treat HIV, but in this study, it is being explored for its potential benefits in lupus patients.
Lamivudine
is another medication included in the trial alongside Abacavir. Like Abacavir, Lamivudine is typically used to treat HIV. In this trial, researchers are investigating whether Lamivudine can also help improve the interferon signature in patients with systemic lupus erythematosus. The combination of these two medications is being added to the standard care to see if it offers additional benefits.

What is already known about the treatment

Abacavir/Lamivudine – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its potential effects on systemic lupus erythematosus, particularly focusing on its impact on the interferon signature in patients. The main therapeutic indication being explored is its use as an add-on treatment to standard care for patients with systemic lupus. At the molecular level, Abacavir and Lamivudine work by inhibiting the replication of viral DNA, which may help modulate immune responses. They are classified as antiretroviral medications, specifically nucleoside reverse transcriptase inhibitors.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with periods of illness, called flares, and periods of wellness, or remission. Symptoms can vary widely among individuals and may include fatigue, joint pain, skin rashes, and fever. Over time, SLE can lead to inflammation and damage in the affected organs. The progression of the disease is unpredictable, with symptoms ranging from mild to severe.