Bictegravir + Lenacapavir for HIV
Trial Summary
Bictegravir, a component of Biktarvy, has been shown to be effective in treating HIV-1 infection, both in patients new to treatment and those switching therapies, with studies indicating it is as effective as other similar drug combinations. It is recommended as a preferred treatment option in HIV guidelines due to its high barrier to resistance and limited drug interactions.
12578Bictegravir/Lenacapavir is unique because it combines two potent components: bictegravir, a novel integrase strand transfer inhibitor (INSTI) with high resistance to mutations, and lenacapavir, which is being explored for its potential long-acting effects. This combination aims to provide a more resilient and possibly longer-lasting treatment option for HIV compared to existing therapies.
12468The trial does not specify if you need to stop your current medications, but it mentions that participants must be on a complex antiretroviral regimen. This suggests you may need to continue your current HIV treatment.
Bictegravir, a component of Biktarvy, is generally well tolerated in humans, with common side effects including diarrhea, nausea, and headache. Real-world studies have shown higher rates of adverse effects and discontinuation compared to clinical trials, but it is considered safe for treating HIV. There is no specific safety data available for the combination of Bictegravir and Lenacapavir.
13678Eligibility Criteria
This trial is for children and adolescents with HIV-1 who are virologically suppressed on a complex ARV regimen. It includes three age-based cohorts: 12-18 years weighing ≥35kg, 6-12 years weighing ≥25 to <35kg, and 2-6 years weighing ≥10 to <25kg. Participants must have no resistance to certain HIV medications and meet specific health criteria like adequate neutrophil count and hemoglobin levels.Inclusion Criteria
Exclusion Criteria
Participant Groups
- HIV-1 infection treatment in adults
- HIV-1 infection treatment in adults
- HIV-1 infection treatment for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection
- HIV-1 infection treatment for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection