Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196638
Status:
TERMINATED
Last Update Posted:
2006-08-29
First Post:
2005-09-12
Brief Title:
Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV InfectionANRS 112 INTERPRIM
Status:
TERMINATED
Status Verified Date:
2006-08
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:
Treatment of acute primary HIV infection may improve long-term outcome However optimal treatment is still debated The ANRS 112-INTERPRIM trial evaluates three different therapeutical strategies combining permanent or intermittent HAART and a cytokine interferon alpha in order to determine which combination allows the best control of HIV viremia after 24 weeks of antiretroviral treatment interruption
Detailed Description:
Treatment of acute primary HIV infection may improve long-term outcome However optimal treatment is still debated The main objective of this multicentric randomized phase IIIII study is to compare HIV viremia 92 and 96 weeks after acute primary HIV infection between patients treated with 3 different strategies In the first group patients receive antiretroviral drugs HAART continuously up to week 72 In the second group patients receive HAART continuously up to week 36 then intermittently up to week 72 In the third group patients receive HAART as in group II and pegylated interferon alpha is administered for the initial 14 weeks then for 3 weeks at each of the 3 HAART interruption between week 36 and week 72 All patients are monitored without any HAART up to week 96 Enrolled patients have circulating p24 antigen andor HIV viremia an uncompleted HIV western blot between 18 and 65 years old and agree to participate to the study They should have received no antiretroviral drugs not be pregnant without neuro-psychological or autoimmune disorders without chronic hepatitis Secondary objectives of the study are the quality of immune restoration the anti-HIV immune response safety and adhesion to treatment A total of 90 patients 30 in each group have been enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None