Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03603977
Status:
RECRUITING
Last Update Posted:
2022-09-14
First Post:
2018-07-19
Brief Title:
Simplified Treatment of Anti-retrovirus in China C-STAR
Sponsor:
Guangzhou 8th Peoples Hospital
Organization:
Guangzhou 8th Peoples Hospital
Study Overview
Official Title:
A Simplified Therapy Regimen Study of Lopinavir and Ritonavir Combined With Lamivudine for HIV-1 Infected Patients in the Real World of China
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word
Detailed Description:
This is an phase IV open-label multicenter single-arm clinical trial in A total of 600 cases were planned to be recruited These cases were given simplified therapy regimen of lopinavir 200mg and ritonavir 50mg 500mg oral bid combined with lamivudine 300mg oral qd The observation duration is thirty-sixth months Patients will be followed up before and 12 24 and 36 months after receiving the simplified regimen observing the viral inhibition rate and the change of CD4 cell count the safety and patientscompliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None