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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07526363

Enrollment

8000

Registered

2026-04-13

Start date

2026-05-01

Completion date

2029-06-01

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opportunistic Infections, HIV Related

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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:

Design outcomes

Primary

Measure	Time frame	Description
Virological suppression rate (HIV RNA < 50 copies/mL)	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	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

Measure	Time frame	Description
Incidence of new opportunistic infections	At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）	Timing, type, and outcome of new opportunistic infections in the follow-up cohort
Incidence of adverse drug events	At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）	Incidence of adverse drug events affecting the liver, kidneys, bones, and nutritional metabolism in both study groups.
Viral Suppression Rate by Opportunistic Infection Subtype and Treatment Duration	At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）	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.
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.)	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.
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.)	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.
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.)	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.

Contacts

CONTACTProf.Yinzhong Shen

shenyinzhong@shphc.org.cn+86 18916113951

Outcome results