In short
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.
Key points
- Clinical trials investigating Abacavir Sulfate are mainly focused on HIV treatment, with one study in amyotrophic lateral sclerosis. Most of the studies are Phase 3 trials, which means they test treatments in larger groups of people. The HIV trials include pregnant women, children, and adults with controlled HIV-1 infection. The studies measure outcomes such as viral rebound, drug levels during pregnancy, and whether switching treatment keeps HIV suppressed. One trial in ALS looks at overall survival over 24 months. The trial data show that Abacavir Sulfate appears in combination treatment studies rather than as a stand-alone research focus.
Trial overview
The trial data show four interventional studies that include Abacavir Sulfate as part of a treatment regimen. These studies are mainly in people with HIV or HIV-1 infection, and one study is in people with amyotrophic lateral sclerosis (ALS).
All four trials are interventional studies, which means the researchers give treatment and measure the results. The studies are mostly Phase 3 trials, so they are testing treatments in larger groups and comparing outcomes.
HIV studies and target populations
Three of the trials are in people with HIV or HIV-1 infection. These studies look at different groups, including pregnant women, children, and adults whose HIV is already well controlled.
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. Its main goal is to describe pharmacokinetics, which means how the body handles the medicines over time.
The pediatric trial, NCT04337450, studies children with HIV aged 2 to under 15 years. It is designed to see whether one treatment approach is not worse than another, which is called non-inferiority. The main outcome is confirmed viral rebound by week 96.
The ISLEND-2 study, NCT06630299, is in virologically suppressed people with HIV-1. This means participants already have low or undetectable virus levels at the start of the study. 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.
ALS study
The Lighthouse II study, NCT05193994, is a Phase 3 trial in people with amyotrophic lateral sclerosis (ALS). It compares Triumeq with placebo, and the placebo was made to match crushed Triumeq tablets in appearance and taste.
The main objective is to assess overall survival, which means the time until death from any cause. The study planned to follow participants for 24 months or until at least 212 events had occurred.
Main endpoints and what they mean
An endpoint is the main result a trial measures to decide whether the treatment worked. In these studies, the endpoints are different because the patient groups and goals are different.
- Overall survival in ALS: the time until death from any cause.
- 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.
- Cord blood/maternal blood ratio: this compares medicine levels in the baby’s blood and the mother’s blood at delivery.
- Half-life in infants: this shows how long it takes the baby’s body to remove the medicine after exposure before birth.
- Breastmilk/maternal plasma ratio: this compares medicine levels in breast milk and in the mother’s blood.
- Confirmed viral rebound by week 96 in children with HIV: this checks whether the virus comes back after being controlled.
- HIV-1 RNA ≥ 50 copies/mL by week 48 in suppressed adults: this measures whether the virus level rises above a set limit.
Study phases and status
All four trials listed are in Phase 3. Phase 3 studies are usually larger and are used to confirm results in real patient groups.
Two studies are marked Completed, and two are marked Authorised. The completed studies include the ALS trial and the pregnancy pharmacokinetic study. The authorised studies include the pediatric HIV trial and the HIV-1 switching study.
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. This includes people with ALS, pregnant women with HIV, children with HIV, and adults with controlled HIV-1 infection.
- People with ALS: studied for survival outcomes in a Phase 3 placebo-controlled trial.
- Pregnant women with HIV: studied to understand medicine levels during pregnancy and after birth.
- Children aged 2 to under 15 years with HIV: studied to see whether treatment keeps the virus suppressed.
- Virologically suppressed people with HIV-1: studied to see whether a switch in treatment keeps HIV under control.