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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Opportunistic Infections, HIV Related

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 Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Prof.Yinzhong Shen; Phone Number: +86 18916113951; Email: shenyinzhong@shphc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
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).	At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of new opportunistic infections	Timing, type, and outcome of new opportunistic infections in the follow-up cohort	At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
Incidence of adverse drug events	Incidence of adverse drug events affecting the liver, kidneys, bones, and nutritional metabolism in both study groups.	At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
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.	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	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.	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	Proportion of participants achieving virological suppression (HIV RNA < lower limit of quantification) among different ART regimen subtypes, assessed at each treatment duration point. Between-group differences in viral suppression rate will be compared.	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	Absolute CD4+ T cell count (cells/mm³) among different ART regimen subtypes, assessed at each follow-up time point. Between-group differences in CD4+ count will be evaluated.	At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Beijing YouAn Hospital; Beijing Ditan Hospital; Peking Union Medical College Hospital; Zhejiang University; The Second Hospital of Nanjing Medical University; Meng Chao Hepatobiliary Hospital of Fujian Medical University; Chest Hospital of Guangxi Zhuang Autonomous Region; Chongqing Public Health Medical Treatment Center; Guangzhou Eighth People's Hospital, Guangzhou Medical University.; GuiYang Public Health Clinical centre; Chengdu Public Health Clinical Medical Centre; Third People's Hospital of Yunnan Province

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Opportunistic Infections; AIDS-Related Opportunistic Infections
• Other Study ID Numbers: Real-World PLWH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO