AIDS
Conditions
Interventions
Control group:Patients diagnosed with CMV-related EOD should be treated according to existing guidelines, while those without diagnostic evidence should not be treated.
Experimental group:Anti-CMV treatment has a fixed course of 3 weeks, with ganciclovir as the first choice. If not tolerated, switch to foscarnet. If subsequent EOD is confirmed ? manage according to t
Sponsors
The Second Hospital of Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-65 years, male or female; 2.Blood CMV DNA >= 10,000 IU/mL; 3.CD4+ T cell count < 100 cells/µL; 4.No confirmed diagnosis of end-organ damage (EOD) prior to enrollment; 5.Able to communicate well with the investigator, willing to participate in the trial after understanding the study content and potential risks, and voluntarily sign the informed consent form approved by the ethics committee;
Exclusion criteria
Exclusion criteria: 1.Confirmed presence of CMV end-organ damage (EOD), including CMV retinitis, CMV encephalitis, CMV pneumonia, CMV esophagitis, CMV enteritis, etc; 2.Concurrent malignancy; 3.Clear contraindication or severe intolerance to ganciclovir or foscarnet sodium; 4.Pregnant or breastfeeding women; 5.Other conditions deemed by the investigator to make the patient unsuitable for participation in the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month all-cause mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune reconstitution status: magnitude of increase in CD4+ T cell count, and changes in HIV RNA.;The value of CMV DNA in different samples (whole blood, serum, plasma, urine) for diagnosing CMV infection, predicting clinical outcomes, and monitoring treatment.;Early anti-CMV regimen (3 weeks) for viral suppression rate and risk of EOD in patients with high CMV viremia.;Safety and occurrence of related adverse events of the early anti-CMV treatment strategy.; | — |
Countries
China
Contacts
Public ContactHongxia Wei
The Second Hospital of Nanjing
Outcome results
None listed