NCT07526363|Not Yet Recruiting
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Sponsor study identifier
observational
8,000
0 countries
N/A
Study Start
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2026
Actual (reported)April 13, 2026
Actual (reported)May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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）
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.)
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.
At baseline, common opportunistic infections common in the AIDS stage were excluded.
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.
First Submitted
April 6, 2026
First Posted
April 13, 2026
Study Start
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 13, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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