This study stratified and compared the differences in virological efficacy and sustained viral suppression status between HIV-infected patients with and without opportunistic infections, providing a basis for optimizing antiretroviral therapy for opportunistic infections and a data foundation for establishing predictive models.
This study employed a multicenter, prospective, controlled, observational real-world cohort design, conducted at key HIV/AIDS treatment hospitals across China. By constructing a large-sample, nationally representative real-world cohort of HIV-infected individuals, it systematically compared the virological efficacy, immune reconstitution, and long-term safety of antiretroviral therapy (ART) between HIV-infected individuals with and without opportunistic infections. This provides high-quality, locally sourced evidence for individualized and optimized ART treatment in HIV-infected patients with opportunistic infections. The total sample size was 8000 individuals, randomly divided in a 1:3 ratio into an opportunistic infection treatment group (2000 individuals with any of the 10 designated opportunistic infections in the HIV co-infection protocol) and a group without opportunistic infections at enrollment (6000 individuals).
Study Type
OBSERVATIONAL
Enrollment
8,000
Virological suppression rate (HIV RNA < 50 copies/mL)
Viral suppression rates (HIV RNA \<50 copies/mL) and inter-group differences were observed in subjects with different HIV RNA strata (≤100,000 copies/mL, 100,000-500,000 copies/mL, and \>500,000 copies/mL, respectively) in two groups with and without opportunistic infections.
Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
CD4+ T cell count
The increase in CD4+ T cell count and the differences between groups were studied at each follow-up time point for subjects with different CD4+ T cell count stratifications (≤50 cells/μL, 50\~100 cells/μL, 100\~200 cells/μL, 200\~350 cells/μL and \>350 cells/μL, respectively).
Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
Incidence of new opportunistic infections
Timing, type, and outcome of new opportunistic infections in the follow-up cohort
Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
Incidence of adverse drug events
Incidence of adverse drug events affecting the liver, kidneys, bones, and nutritional metabolism in both study groups.
Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
Viral Suppression Rate by Opportunistic Infection Subtype and Treatment Duration
Proportion of participants achieving virological suppression (HIV RNA \< lower limit of quantification) among different opportunistic infection subtypes within the opportunistic infection treatment group, assessed at each treatment duration point. Between-group differences in viral suppression rate will be compared.
Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
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CD4+ T Cell Count Increase by Opportunistic Infection Subtype and Follow-up Time Point
Change from baseline in CD4+ T cell count (cells/mm³) among different opportunistic infection subtypes within the opportunistic infection treatment group, assessed at each follow-up time point. Between-group differences in CD4+ gain will be evaluated.
Time frame: At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)
Viral Suppression Rate by ART Regimen Subtype and Treatment Duration
Proportion of participants achieving virological suppression (HIV RNA \< lower limit of quantification) among different ART regimen subtypes, assessed at each treatment duration point. Between-group differences in viral suppression rate will be compared.
Time frame: At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)
CD4+ T Cell Count by ART Regimen Subtype and Follow-up Time Point
Absolute CD4+ T cell count (cells/mm³) among different ART regimen subtypes, assessed at each follow-up time point. Between-group differences in CD4+ count will be evaluated.
Time frame: At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)