www.catie.caChloroquine as a modulator of T cell immune activation to improve CD4 recovery in HIV-infected participants receiving antiretroviral therapy: A proof-of-concept study
About the study
This study will evaluate the effect of chloroquine in individuals infected with HIV. Researchers will aim to determine if chloroquine treatment in participants whose viral loads are suppressed on combination antiretroviral therapy (ART), results in improved immune activation and CD4 cell recovery.
The study will recruit 20 individuals and will last approximately 44 weeks. Eligible participants will receive an oral dose of chloroquine (250 mg) once daily from week 8 through week 32. All participants will be asked to have rectal biopsy samples (week 0 and week 32) to study T cell immune activation in the mucosa rectal site.
About the disease/condition
Up to 30% of individuals successfully treated with ART do not achieve a strong CD4 T cell recovery and therefore, remain at risk for AIDS and non-AIDS infections and diseases. Among factors associated with low CD4 T cell recovery is T cell activation, which stimulates Toll-like receptors (TLR). TLR play a crucial role in this innate immune response. Researchers hope that by blocking TLR engagement by chloroquine, an antimalarial medication, T cell immune activation would be reduced and in turn would promote CD4 recovery when HIV replication is suppressed by ART.
Study Approach
Clinical data has identified chloroquine as a potential modulator of immune activation.
The study’s dose of chloroquine is the same as the dose recommended for patients having autoimmune diseases. In these autoimmune cases, a daily dose of chloroquine at 250 mg for 12 weeks has shown improvement in symptoms and decreases in inflammatory cytokines synthesis and a reduction in TLR –mediated immune activation.
Study findings could help provide information about where and under what circumstances chloroquine treatment may reduce T cell activation and help restore circulating CD4 T cells.