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Effect of switching to a regimen based on second-generation integrase inhibitors or protease inhibitors on virologic regression of hypoviremia in HIV-infected patients

Effect of switching to a regimen based on second-generation integrase inhibitors or protease inhibitors on virologic regression of hypoviremia in HIV-infected patients

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076417
Enrollment
Unknown
Registered
2023-10-08
Start date
2023-10-10
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

AIDS

Interventions

exposure group (Conversion to programs based on second-generation INSTIs or PIs):NA
control group (Continuous TDF/3TC/EFV):NA

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) HIV antibody positivity by ELISA and Western Blot, or HIV viral load = 5000 copies/mL; 2) Recent HIV viral load above 50 copies/mL and below 1000 copies/mL; 3) ART treatment with TDF/3TC/EFV regimen for more than 6 months; 4) Achieving viral suppression (HIV viral load <50 copies/mL) at least once after ART; 5) Age 18 or above (inclusive); 6) Volunteer to participate in the study, complete all follow-ups according to the requirements of the program and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients who refuse to provide ICFs; 2) Suffering from organic mental illness; 3) Pregnancy; 4) contradictory to treatment with second-generation INSTIs or PIs; 5) any other condition deemed by the investigator to be inappropriate for the study; 6) known history of resistance to tenofovir, lamivudine or efavirenz. ; 7) Plans to switch regimens after enrollment and before study endpoints.

Design outcomes

Primary

MeasureTime frame
HIV viral load;

Secondary

MeasureTime frame
CD4 cell;CD4+/CD8+;

Countries

China

Contacts

Public ContactChen Jun

Shanghai Public Health Clinical Center

qtchenjun@163.com+86 180 1750 0639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026