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).

Inclusion Criteria:

• For the opportunistic infection treatment group: Inclusion criteria: a) Age ≥ 18 years, diagnosed with HIV-1 infection; b) Clinically diagnosed with one of the following opportunistic infections and initiating anti-infective therapy: PCP, tuberculosis, NTM infection, CMV infection, herpes simplex virus and varicella-zoster virus infection, toxoplasmosis encephalopathy, oral fungal infection, cryptococcal meningitis, Marneffei basket disease, PML; c) Intending to initiate ART therapy or currently receiving ART therapy; d) The individual (or their legal representative) voluntarily signs a written informed consent form.
• For the non-opportunistic infection group: a) Age ≥ 18 years, diagnosed with HIV-1 infection; b) Intending to start ART treatment or currently receiving ART treatment; c) The individual (or legal representative) voluntarily signs a written informed consent form.

Exclusion Criteria:

• For the opportunistic infection treatment group: Exclusion criteria: a) Individuals suffering from major neurological or psychiatric illnesses such as schizophrenia, epilepsy, or severe depression; b) Individuals with a history of drug use or recent history of alcohol or drug dependence; c) Individuals deemed unsuitable for participation by researchers, such as those in the acute phase of severe cardiovascular disease; d) Individuals deemed unsuitable for participation by other researchers; e) Individuals whose long-term follow-up requirements and frequency cannot be guaranteed.
• For the non-opportunistic infection group: a) Individuals with coexisting opportunistic infections; b) Individuals suffering from major neurological or psychiatric illnesses such as schizophrenia, epilepsy, or severe depression; c) Individuals with a history of drug use or recent history of alcohol or drug dependence; d) Individuals deemed unsuitable for participation by researchers, such as those in the acute phase of severe cardiovascular disease; e) Individuals deemed unsuitable for participation by other researchers; f) Individuals whose long-term follow-up requirements and frequency cannot be guaranteed.

The study population consists of HIV-infected adults (age ≥18 years) diagnosed with at least one opportunistic infection, including but not limited to Pneumocystis jirovecii pneumonia, tuberculosis, and cytomegalovirus infection. Participants are further categorized by the type of opportunistic infection and by the specific antiretroviral therapy (ART) regimen received (e.g., NNRTI-based, PI-based, or INSTI-based regimens). All participants are enrolled from [clinic name / multi-center study] and have available viral load and CD4+ T cell count measurements at baseline and at scheduled follow-up time points.