Trends in HIV clinical trials in India: An analysis of Clinical Trials Registry of India data (2008–2025)
Year: 2025
Type: article
Abstract: INTRODUCTION The HIV epidemic in India remains a significant public health challenge despite notable progress over the past decades. According to recent estimations, over 2.5 million people are living with HIV in India, with an adult prevalence rate of approximately 0.2% and an estimated 66,400 new HIV infections annually.[1] Clinical trials are essential for advancing HIV prevention, treatment, and care. Projections indicate that 37% of HIV-positive individuals will be over 50 by 2025, reflecting increased longevity from antiretroviral therapy.[2] The Clinical Trials Registry of India (CTRI), established in 2007, provides a comprehensive database of clinical trials conducted in India, with mandatory registration since June 2009.[3] This study analyses the trends in HIV clinical trials registered in CTRI between 2008 and 2025, providing insights into the evolving landscape of HIV research in India and its global collaborations. METHODS Data were extracted from the CTRI database using keywords “HIV,” “Antiretroviral” and related medications. All 156 HIV-related clinical trials registered between January 2008 and prospective registrations up to 2025 were included. Information was analyzed based on registration year, trial type (interventional/observational), study type (drug, vaccine, behavioral, etc.), sponsorship patterns, postgraduate thesis status, and international collaboration descriptive statistics were used to analyze trends over four time periods: 2008–2012, 2013–2017, 2018–2021 and 2022–2025, using SPSS Version 21 (IBM Corporation, Armonk, New York, USA). RESULTS Among the 156 HIV-related clinical trials, 102 (65.4%) were interventional and 54 (34.6%) were observational. Peak registrations occurred in 2018 (12.2%) and 2021 (11.5%). Drug trials constituted the largest intervention category (37.8%), and complementary medicine approaches including Yoga, Naturopathy, Ayurveda, Homeopathy, and Siddha combined (9%) of interventional trials. Government agencies were the primary funding source (41.0%), followed by pharmaceutical industry sponsors (20.5%) and self-funded studies (14.1%). Nearly one-third (30.1%) of studies were conducted as part of postgraduate thesis work, with observational studies comprising 63% of these academic investigations. International collaboration was observed in 22 trials (14.1%), primarily with South Africa (n = 20), the United States (n = 10), and Thailand (n = 10), followed by other South African, South American, and South East Asian countries. These collaborative trials were predominantly supported by government funding agencies (77.2%). Temporal analysis revealed substantive methodological transitions: observational studies increased markedly from 3.3% in 2008–2012 to 50% in 2022–2025, whereas drug trials declined from 63.3% to 33.3% over the study period. Vaccine trials disappeared after 2017, and complementary medicine approaches showed growth from 23.3% to 61.9%. International collaborations decreased proportionally from 36.6% to 4.7%, suggesting greater focus on local research priorities. DISCUSSION Our analysis reveals important patterns in the HIV research landscape in India. The fluctuating number of trial registrations likely reflects changing research priorities, funding opportunities, and regulatory environments. The predominance of drug trials in earlier years aligns with global HIV research priorities, wherewas the gradual diversification toward behavioral interventions and complementary medicine approaches indicates an evolution toward a more comprehensive research agenda.[4] The substantial government funding demonstrates a strong national commitment to addressing the HIV epidemic through research. The significant proportion of academic institution-sponsored trials further indicates domestic capacity and commitment to HIV research. The increasing proportion of observational studies suggests growing attention to implementation science, healthcare delivery, and epidemiological monitoring, aligning with global trends in HIV research.[5] The absence of vaccine trials in later periods (2018–2025) is noteworthy and may reflect a global shift in HIV vaccine research priorities or funding. The diversification toward complementary medicine approaches reflects India’s unique contribution to HIV research, as traditional medicine systems may offer complementary approaches to managing HIV infection and treatment side effects.[6] While international collaborative trials showed a proportional decrease over time, India’s continued participation in global research networks positions it to contribute significantly to future HIV research priorities, including optimizing prevention strategies for key populations, addressing comorbidities in aging populations with HIV, and developing implementation approaches to achieve global targets for HIV elimination. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Authors: Arunkumar Ramaraj, Natarajan Thangam Nivasini, M. Vikram Balaji, Jerin James, Sathyanarayanan Varadarajan
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4410859216