Opportunistic Infections, HIV RelatedNCT07526363
Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections
An observational study of Opportunistic Infections, HIV Related, run by Shanghai Public Health Clinical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opportunistic Infections, HIV Related
- Type of treatment
- Pill or oral medicine
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Jun 2029
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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).
- Conditions
- Opportunistic Infections, HIV Related
- Medical subject headings
- AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）
Secondary outcomes (6)
Incidence of new opportunistic infections
Timing, type, and outcome of new opportunistic infections in the follow-up cohort
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At each scheduled follow-up time point (6 months,12 months, 24 months and etcs.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opportunistic Infections, HIV RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Collaborators
- Chest Hospital of Guangxi Zhuang Autonomous Region, Beijing Ditan Hospital, Guangzhou Eighth People's Hospital, Guangzhou Medical University., The Second Hospital of Nanjing Medical University, Chongqing Public Health Medical Treatment Center, GuiYang Public Health Clinical centre, Chengdu Public Health Clinical Center, The Third People's Hospital of Yunnan Province, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Beijing YouAn Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Zhejiang University
- Responsible party
- Principal investigator, Yinzhong Shen, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526363
- Sponsor's protocol ID
- Real-World PLWH
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections
- ClinicalTrials.gov ID
- NCT07526363
- Acronym / sponsor ID
- Real-World PLWH
- Conditions
- Opportunistic Infections, HIV Related
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Collaborators
- Chest Hospital of Guangxi Zhuang Autonomous Region, Beijing Ditan Hospital, Guangzhou Eighth People's Hospital, Guangzhou Medical University., The Second Hospital of Nanjing Medical University, Chongqing Public Health Medical Treatment Center, GuiYang Public Health Clinical centre, Chengdu Public Health Clinical Center, The Third People's Hospital of Yunnan Province, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Beijing YouAn Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Zhejiang University
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
6 secondary outcomes
Incidence of new opportunistic infections
Time frame: 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）
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）
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.)
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.)
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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Opportunistic Infections, HIV Related, run by Shanghai Public Health Clinical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof.Yinzhong Shen (+86 18916113951, shenyinzhong@shphc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virological suppression rate (HIV RNA < 50 copies/mL) (time frame: At each scheduled treatment duration point（6 months, 12 months, 24 months and etcs）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.