Immunomodulators as adjunctive therapy for HIV-1 infection

Area of Science:

• Immunology
• Virology
• Clinical Research

Background:

• Renewed interest exists in using immunotherapy alongside antiretroviral therapy (ART) for HIV treatment.
• Interleukin-2 (IL-2) has shown promise in increasing CD4(+) T cell counts in previous studies.
• The clinical impact of IL-2-induced CD4(+) T cell increases requires further investigation.

Purpose of the Study:

• To evaluate the safety and immunological/virological effects of intermittent subcutaneous IL-2 in ART-naïve HIV-1 patients.
• To assess the impact of IL-2 on CD4(+) T cell counts and plasma HIV RNA levels.
• To provide data for larger clinical endpoint studies like ESPRIT and SILCAAT.

Main Methods:

• An open-label, randomized study comparing subcutaneous IL-2 (4.5 or 7.5 MIU) every 8 weeks versus no therapy.
• Participants were HIV-1 infected individuals with a baseline CD4(+) T cell count > or = 350 cells/mm(3).
• Primary endpoints included changes in CD4(+) T cell count and plasma HIV RNA.

Main Results:

• Significant differences in the area under the curve (AUC) change from baseline CD4(+) T cell count (P = 0.001) were observed.
• Mean absolute CD4(+) T cell counts also showed a significant increase (P = 0.04).
• No significant difference in mean AUC change from baseline plasma HIV RNA was found between IL-2 and control groups (P = 0.48).

Conclusions:

• Intermittent subcutaneous IL-2 therapy can sustainably increase CD4(+) T cell counts in HIV-1 infected individuals.
• IL-2 treatment did not adversely affect plasma HIV RNA levels in this study.
• These findings support further investigation into IL-2 as an adjunct to ART for HIV management.