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Abacavir

Clinical trials investigating Abacavir are studying how it is used in people with HIV-1 and in patients with systemic lupus. The trials look at treatment effects, viral control, immune changes, and other outcomes in adults and children. Some studies also include people with perinatal HIV infection or virologically suppressed HIV-1.

Table of Contents

Clinical trial overview

These studies investigate Abacavir in different clinical settings, mainly HIV-1 infection and one study in systemic lupus.[1][2][3] The trials are designed to assess treatment effects, disease control, and immune-related outcomes in specific patient groups.[1][2][3]

HIV-1 studies

One Phase 3 study, the ITACO and ITACO-ATI project, follows people with perinatally HIV infection and is focused on the HIV reservoir, which means hidden virus inside body cells.[1] The study aims to build a predictive platform called PredictHIV to help select patients for analytical antiretroviral treatment interruption, which is a planned stop of HIV treatment under close study conditions.[1]

The ITACO-ATI part looks at whether HIV proviruses in certain chromatin regions can predict delayed viral rebound during treatment interruption.[1] It also measures changes in the intact proviral reservoir after treatment is restarted and studies innate and adaptive immune cell frequency and function.[1]

A second Phase 3 study, ISLEND-2, includes virologically suppressed people with HIV-1 and compares a weekly oral islatravir/lenacapavir regimen with standard of care at Week 48.[2] Abacavir appears in the list of standard treatment options used in the study, including the combination lamivudine, Abacavir and dolutegravir.[2]

Systemic lupus study

The PENCIL trial is a randomized, controlled Phase 2 proof-of-concept study in people with systemic lupus and low disease activity.[3] It tests the Abacavir/lamivudine combination as an add-on to standard care for 6 months and compares the change in the interferon signature across the total, pediatric, and adult populations.[3]

The interferon signature is measured using gene activity from six interferon-inducible genes: IFI27, IFI44L, IFIT1, ISG15, RSAD2, and SIGLEC.[3] This makes the study a proof-of-concept trial, meaning it is checking early evidence that the approach may affect a biological marker linked to disease activity.[3]

Who can take part

The trial populations are specific and not general to all patients.[1][2][3] The HIV studies include people with perinatal HIV infection and people with HIV-1 who are already suppressed on treatment.[1][2] The lupus study includes patients with low disease activity, and the results are reported for both pediatric and adult groups.[3]

  • People with perinatal HIV infection are included in the ITACO study, which focuses on long-term HIV reservoir behavior.[1]

  • People with HIV-1 infection who are already virologically suppressed are included in the ISLEND-2 study.[2]

  • People with systemic lupus and low disease activity are included in the PENCIL study.[3]

What the trials measure

The main outcomes are different in each study, but they all focus on measurable clinical or biological changes.[1][2][3] In the ITACO study, the main outcome is the proportion of patients with no HIV intact proviruses or with proviruses in specific heterochromatin positions, which are tightly packed DNA regions that are less active.[1]

In ITACO-ATI, the key outcome is the proportion of “PredictHIV negative” patients who undergo analytical treatment interruption and the related changes in reservoir behavior during and after treatment stop and restart.[1] In ISLEND-2, the main outcome is the proportion of participants with HIV-1 RNA of at least 50 copies/mL at Week 48, using the FDA-defined snapshot algorithm, which is a standard way to summarize trial results at a fixed time point.[2]

In PENCIL, the main outcome is the absolute change in interferon signature from the start of treatment to 6 months.[3] The study also looks at the total population and then separately at pediatric and adult populations.[3]

Trial phases and status

All three studies are interventional trials, which means researchers assign a treatment or treatment strategy and then measure outcomes.[1][2][3] Two studies are Phase 3 trials: ITACO/ITACO-ATI is completed, and ISLEND-2 is authorised.[1][2]

The PENCIL study is a Phase 2 trial and is authorised.[3] The enrollment sizes are 61 for ITACO/ITACO-ATI, 634 for ISLEND-2, and 72 for PENCIL.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollment
2024-518694-33-00Phase 3Perinatally HIV infectionCompleted61
NCT06630299Phase 3HIV-1 InfectionAuthorised634
NCT06356740Phase 2Systemic lupusAuthorised72

FAQ

  • What are the Abacavir clinical trials studying? They are studying Abacavir in HIV-1 and systemic lupus. The trials look at treatment response, viral rebound, and immune-related measures.
  • Who may take part in these trials? The trial groups include people with perinatal HIV infection, people with HIV-1 who are virologically suppressed, and patients with systemic lupus. Some studies also separate pediatric and adult participants.
  • What phases are the Abacavir trials? The trials listed are Phase 2 and Phase 3 studies. This means they are testing clinical effects in larger patient groups.
  • What outcomes are being measured? The studies measure outcomes such as HIV-1 RNA levels, viral rebound after treatment interruption, and the interferon signature in lupus. Some also assess immune cell frequency and proviral reservoir changes.
  • Are these Abacavir studies all in the same disease? No. Most trials are in HIV-1, but one trial studies systemic lupus. This shows Abacavir is being tested in different clinical settings.

Ongoing Clinical Trials on Abacavir

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

    Recruiting

    1 1 1
    Investigated drugs:
    France

  • Study on HIV Treatment Interruption in Children with Perinatal HIV Using Lamivudine and Drug Combination

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study Comparing Weekly Islatravir/Lenacapavir Regimen to Standard Care in HIV Patients with Controlled Viral Load

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany The Netherlands Poland Spain

Glossary

  • HIV-1: A type of human immunodeficiency virus. The trials study people living with HIV-1 and how treatment changes virus control.
  • Perinatal HIV infection: HIV infection passed from mother to baby around pregnancy, birth, or shortly after birth.
  • Virologically suppressed: A state where the amount of virus in the blood is very low or not detected with standard tests.
  • Analytical antiretroviral treatment interruption: A planned and closely watched stop of HIV treatment for research. It is used to see how quickly the virus comes back.
  • Viral rebound: When the virus level rises again after treatment is stopped.
  • Proviral reservoir: Cells in the body that hold hidden HIV genetic material. These cells can make HIV harder to fully remove.
  • Chromosomal integration: The way HIV genetic material becomes inserted into human DNA inside a cell.
  • Interferon signature: A pattern of gene activity linked to the body’s immune response. In the lupus study, it is measured using specific genes.
  • Lupus Low Disease Activity State (LLDAS): A state where lupus is present but disease activity is low and more stable.
  • Phase 2: A trial stage that looks more closely at whether a treatment works and how it affects patients.
  • Phase 3: A later trial stage with larger groups of patients, used to confirm effects and compare treatments.

References