Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections

Обзор

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.

Подробное описание

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).

Первичные конечные точки

• Virological suppression rate (HIV RNA < 50 copies/mL) [Срок оценки: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）]
• CD4+ T cell count [Срок оценки: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）]

Вторичные конечные точки (6)

• Incidence of new opportunistic infections [Срок оценки: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）]
• Incidence of adverse drug events [Срок оценки: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）]
• Viral Suppression Rate by Opportunistic Infection Subtype and Treatment Duration [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07526363 · Real-World PLWH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗