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

NCT07526363 | Not Yet Recruiting

• 1 other identifier: Real-World PLWH
• Study Type: observational
• Target: 8,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opportunistic Infections, HIV Related

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Incidence of new opportunistic infections

  At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）

• Incidence of adverse drug events

  At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）

• Viral Suppression Rate by Opportunistic Infection Subtype and Treatment Duration

  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

  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

  At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead
• Chest Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Beijing Ditan Hospital: 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 Medical Centre: collaborator
• Third People's Hospital of Yunnan Province: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• Zhejiang University: collaborator
• Guangzhou Eighth People's Hospital, Guangzhou Medical University.: collaborator
• Beijing YouAn Hospital: collaborator
• Peking Union Medical College Hospital: collaborator

MeSH Terms

Conditions

AIDS-Related Opportunistic Infections

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Opportunistic Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Prof.Yinzhong Shen

CONTACT

+86 18916113951; shenyinzhong@shphc.org.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share