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Abacavir Sulfate

Clinical trials investigating Abacavir Sulfate are studying how it is used in different treatment settings, mainly for people with HIV and in one study for amyotrophic lateral sclerosis (ALS). These trials look at outcomes such as viral control, pharmacokinetics, and overall survival. They include adults, pregnant women, children, and virologically suppressed people with HIV.

Table of Contents

Trial overview

The trial data show four interventional studies that include Abacavir Sulfate as part of a treatment regimen.[1][2][3][4] These studies are mainly in people with HIV or HIV-1 infection, and one study is in people with amyotrophic lateral sclerosis (ALS).[1][2][3][4]

All four trials are interventional studies, which means the researchers give treatment and measure the results.[1][2][3][4] The studies are mostly Phase 3 trials, so they are testing treatments in larger groups and comparing outcomes.[1][2][3][4]

HIV studies and target populations

Three of the trials are in people with HIV or HIV-1 infection.[2][3][4] These studies look at different groups, including pregnant women, children, and adults whose HIV is already well controlled.[2][3][4]

The PANNA study, NCT00825929, is a Phase 3 trial in HIV-infected pregnant women and also looks at infants after exposure in the womb, and in some cases during breastfeeding.[2] Its main goal is to describe pharmacokinetics, which means how the body handles the medicines over time.[2]

The pediatric trial, NCT04337450, studies children with HIV aged 2 to under 15 years.[3] It is designed to see whether one treatment approach is not worse than another, which is called non-inferiority.[3] The main outcome is confirmed viral rebound by week 96.[3]

The ISLEND-2 study, NCT06630299, is in virologically suppressed people with HIV-1.[4] This means participants already have low or undetectable virus levels at the start of the study.[4] The study compares a weekly oral regimen with standard care and measures whether HIV-1 RNA rises to 50 copies/mL or more by week 48.[4]

ALS study

The Lighthouse II study, NCT05193994, is a Phase 3 trial in people with amyotrophic lateral sclerosis (ALS).[1] It compares Triumeq with placebo, and the placebo was made to match crushed Triumeq tablets in appearance and taste.[1]

The main objective is to assess overall survival, which means the time until death from any cause.[1] The study planned to follow participants for 24 months or until at least 212 events had occurred.[1]

Main endpoints and what they mean

An endpoint is the main result a trial measures to decide whether the treatment worked.[1][2][3][4] In these studies, the endpoints are different because the patient groups and goals are different.[1][2][3][4]

  • Overall survival in ALS: the time until death from any cause.[1]

  • AUC0-tau, Cmax, Ctrough, tmax, and thalf in pregnancy: these are blood-level measures that show how much medicine is in the body, when the highest level happens, and how long it stays there.[2]

  • Cord blood/maternal blood ratio: this compares medicine levels in the baby’s blood and the mother’s blood at delivery.[2]

  • Half-life in infants: this shows how long it takes the baby’s body to remove the medicine after exposure before birth.[2]

  • Breastmilk/maternal plasma ratio: this compares medicine levels in breast milk and in the mother’s blood.[2]

  • Confirmed viral rebound by week 96 in children with HIV: this checks whether the virus comes back after being controlled.[3]

  • HIV-1 RNA ≥ 50 copies/mL by week 48 in suppressed adults: this measures whether the virus level rises above a set limit.[4]

Study phases and status

All four trials listed are in Phase 3.[1][2][3][4] Phase 3 studies are usually larger and are used to confirm results in real patient groups.[1][2][3][4]

Two studies are marked Completed, and two are marked Authorised.[1][2][3][4] The completed studies include the ALS trial and the pregnancy pharmacokinetic study.[1][2] The authorised studies include the pediatric HIV trial and the HIV-1 switching study.[3][4]

Who the trials are designed for

The trial data show that Abacavir Sulfate appears in studies for several patient groups, not just one type of participant.[1][2][3][4] This includes people with ALS, pregnant women with HIV, children with HIV, and adults with controlled HIV-1 infection.[1][2][3][4]

  • People with ALS: studied for survival outcomes in a Phase 3 placebo-controlled trial.[1]

  • Pregnant women with HIV: studied to understand medicine levels during pregnancy and after birth.[2]

  • Children aged 2 to under 15 years with HIV: studied to see whether treatment keeps the virus suppressed.[3]

  • Virologically suppressed people with HIV-1: studied to see whether a switch in treatment keeps HIV under control.[4]

Trial ID Phase Condition studied Status Enrollment
NCT05193994 Phase 3 Amyotrophic lateral sclerosis Completed 419
NCT00825929 Phase 3 HIV-infected Completed 211
NCT04337450 Phase 3 HIV-infected Authorised 386
NCT06630299 Phase 3 HIV-1 infection Authorised 634

FAQ

  • What are clinical trials with Abacavir Sulfate studying? The trials are studying Abacavir Sulfate as part of HIV treatment regimens and in one ALS study. They measure outcomes such as viral rebound, drug levels in pregnancy, and overall survival.
  • Who can take part in these trials? The target groups include HIV-infected pregnant women, children with HIV aged 2 to under 15 years, virologically suppressed people with HIV-1, and people with ALS. Each trial has its own entry rules.
  • What trial phases are listed? The trials are mainly Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to compare results and confirm benefits.
  • What conditions are being studied? The main condition is HIV infection, including HIV-1 infection. One trial also studies amyotrophic lateral sclerosis, a serious nerve disease that affects movement.
  • What outcomes are measured in these trials? The trials measure outcomes such as confirmed viral rebound, drug exposure in the mother and baby, and overall survival. These outcomes help show whether the treatment is working as expected.

Ongoing Clinical Trials on Abacavir Sulfate

  • Study on Dolutegravir and Lamivudine for Maintaining Viral Control in Children with HIV Aged 2 to Under 15 Years

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • 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

  • Study on the Effects of Triumeq (Abacavir Sulfate, Lamivudine, Dolutegravir Sodium) in Patients with Amyotrophic Lateral Sclerosis (ALS)

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Ireland The Netherlands Slovenia Spain Sweden

  • Study on the Effects of Abacavir Sulfate and Etravirine in Pregnant Women with HIV

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Germany Ireland The Netherlands Spain

Glossary

  • Clinical trial: A planned research study in people. It is used to test whether a treatment is helpful, safe, or works better than another option.
  • Phase 3: A later stage of testing in larger groups of people. It usually compares a treatment with another treatment, placebo, or standard care.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Virologically suppressed: When the amount of virus in the blood is very low or not detected. In these trials, it means HIV is well controlled.
  • Viral rebound: When the virus level rises again after being controlled. One trial measures the first confirmed rise in HIV-1 RNA.
  • Pharmacokinetics: How the body absorbs, moves, and removes a medicine. The pregnancy study measures this in mothers, babies, and breast milk.
  • AUC0-tau: A measure of total drug exposure over a dosing interval. It helps show how much medicine is in the body over time.
  • Cmax: The highest level of a medicine in the blood after a dose.
  • Ctrough: The lowest level of a medicine in the blood before the next dose.
  • Amyotrophic lateral sclerosis (ALS): A serious disease that affects nerve cells and causes weakness and loss of muscle control.

References