Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 8,000
- Primary Endpoint
- Virological suppression rate (HIV RNA < 50 copies/mL)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Opportunistic infection treatment group
Based on the presence of baseline: PCP, tuberculosis, NTM infection, CMV infection, herpes simplex and varicella-zoster virus infection, toxoplasmosis encephalopathy, oral fungal infection, cryptococcal meningitis, Marneffei basket disease, PML is divided into opportunistic infection groups.
Non-opportunistic infection group
At baseline, common opportunistic infections common in the AIDS stage were excluded.
Outcomes
Primary Outcomes
Virological suppression rate (HIV RNA < 50 copies/mL)
Time Frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
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.
CD4+ T cell count
Time Frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
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).
Secondary Outcomes
- Incidence of new opportunistic infections(At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）)
- Incidence of adverse drug events(At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）)
- Viral Suppression Rate by Opportunistic Infection Subtype and Treatment Duration(At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）)
- CD4+ T Cell Count Increase by Opportunistic Infection Subtype and Follow-up Time Point(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(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(At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.))
Investigators
Yinzhong Shen
Professor
Shanghai Public Health Clinical Center