Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Opportunistic Infections, HIV Related. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Primary outcome measures
- Virological suppression rate (HIV RNA < 50 copies/mL) [Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）]
- CD4+ T cell count [Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）]
Secondary outcome measures (6)
- Incidence of new opportunistic infections [Time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）]
- Incidence of adverse drug events [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 [Time frame: 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 [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 [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 [Time frame: At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07526363 · Real-World PLWH