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

April 6, 2026 updated by: Yinzhong Shen, Shanghai Public Health Clinical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Virological suppression rate (HIV RNA < 50 copies/mL)
Time Frame: 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.
At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
CD4+ T cell count
Time Frame: 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).
At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of new opportunistic infections
Time Frame: 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
At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
Incidence of adverse drug events
Time Frame: 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.
At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
Viral Suppression Rate by Opportunistic Infection Subtype and Treatment Duration
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Public Health Clinical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Real-World PLWH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings