Human Immunodeficiency Virus: From Clinical Studies to Patient Outcomes

Dear Colleagues,

Human Immunodeficiency Virus (HIV) has been the focus of extensive clinical research for more than four decades, and this scientific effort has transformed the course of HIV infection from a rapidly progressive and often fatal disease into a manageable chronic condition. Early clinical studies were fundamental for characterizing routes of transmission, elucidating the mechanisms of CD4+ T-cell depletion, and describing the natural course of untreated infection. These investigations provided the foundation for the development of antiretroviral therapy (ART) and enabled evidence-based approaches to patient management.

Randomized controlled trials were pivotal in identifying effective antiretroviral drug classes and optimizing combination regimens capable of achieving durable suppression of viral replication. The advent of highly active antiretroviral therapy (HAART) in the mid-1990s represented a major breakthrough, demonstrating that sustained viral suppression prevents immunological decline and markedly reduces the incidence of opportunistic infections and HIV-related mortality. Subsequent generations of ART, particularly integrase strand transfer inhibitors, have further improved clinical outcomes by offering enhanced potency, higher genetic barriers to resistance, and better safety profiles.

Clinical evidence has also shaped public health strategies. Large cohort studies and interventional trials have demonstrated that individuals maintaining an undetectable viral load do not transmit HIV through sexual contact, supporting the “U=U” (Undetectable = Untransmittable) framework. This finding has substantially influenced global prevention strategies and contributed to stigma reduction, while emphasizing the importance of early diagnosis and adherence to therapy.

More recently, research has expanded beyond virological and immunological endpoints to include patient-centered outcomes such as quality of life, mental health, metabolic complications, and the challenges associated with aging with HIV. Implementation science has further identified structural and social barriers to care, informing interventions to improve linkage, retention, and treatment equity across diverse populations.

Ongoing clinical trials continue to advance long-acting formulations, immune-based therapies, and curative strategies. Collectively, the trajectory from early clinical studies to contemporary patient-focused research highlights the substantial progress made in HIV care and underscores the need for sustained scientific innovation to further improve long-term outcomes.

Prof. Dr. Vítor Duque
Guest Editor

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• HIV/AIDS
• clinical trials
• patient outcomes
• clinical translational research