Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Public Health Clinical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
8,000 Participants
are grouped into 2 trial groupsGroup A: Opportunistic infection treatment group
Group B: Non-opportunistic infection group
Trial outcomes
Primary outcomes
1
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）2
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）Secondary outcomes
1
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）2
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）3
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）4
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.)Locations
Sponsors and contacts
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Shanghai Public Health Clinical Center
Lead sponsor
Chest Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Beijing Ditan Hospital
Collaborator
Guangzhou Eighth People's Hospital, Guangzhou Medical University.
Collaborator
The Second Hospital of Nanjing Medical University
Collaborator
Chongqing Public Health Medical Treatment Center
Collaborator
GuiYang Public Health Clinical centre
Collaborator
Chengdu Public Health Clinical Center
Collaborator
The Third People's Hospital of Yunnan Province
Collaborator
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Collaborator
Beijing YouAn Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
Zhejiang University
Collaborator
Source ClinicalTrials.gov
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