Trial results evaluating the incidence of HIV-associated non-AIDS (HANA) conditions in HIV-infected individuals were posted on ClinicalTrials.gov on 2025-12-09. This completed study enrolled 215 participants to assess the prevalences of various HANA conditions across different antiretroviral regimens.
Background
With advancements in anti-retroviral therapy (ART), HIV-infected individuals are experiencing longer life expectancies, shifting the focus of clinical management beyond AIDS-defining illnesses. HIV-associated non-AIDS (HANA) conditions, such as metabolic syndrome, osteopenia, osteoporosis, and vitamin D deficiency, are increasingly recognized as significant concerns. It has been uncertain whether different ART regimens might influence the incidence of these HANA conditions. This study aimed to evaluate their prevalence in a cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating ART.
Trial design
This completed study enrolled 215 participants. The trial investigated conditions including HIV, Metabolic Syndrome, Osteopenia, Osteoporosis, and Vitamin D Deficiency. The study evaluated the prevalence of HANA conditions in a cohort of newly diagnosed HIV-infected individuals initiating anti-retroviral treatment, categorizing participants into INSTI (integrase strand transfer inhibitor) and non-INSTI treatment groups for analysis.
Key results
The study reported on the prevalences of HIV-associated Non-AIDS Conditions (HANA) across the two treatment groups. The number of participants affected by various HANA conditions were:
- In the INSTI group: 69, 30, 79, 85, 60, and 72 participants.
- In the non-INSTI group: 15, 4, 9, 17, 16, and 9 participants.
Key analyses using the Chi-squared method for these prevalences reported the following p-values:
- 0.244
- 0.584
- 0.067
- 0.365
- 0.033
- 0.196
What this means
The results indicate varying prevalences of HIV-associated non-AIDS conditions among individuals treated with INSTI-based versus non-INSTI antiretroviral regimens. Most of the Chi-squared analyses yielded p-values greater than 0.05 (0.244, 0.584, 0.067, 0.365, 0.196), suggesting no statistically significant difference in the prevalence of those specific HANA conditions between the two treatment groups in this cohort. However, one analysis showed a statistically significant difference with a p-value of 0.033, indicating a potential difference in the prevalence of one HANA condition between the INSTI and non-INSTI groups. This highlights the ongoing need to understand the long-term impact of different ART regimens on the development of non-AIDS comorbidities.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03483584, titled "Incidence of HANA Conditions in HIV-infected Individuals", were posted on 2025-12-09 on clinicaltrials.gov.