Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158405
Status:
COMPLETED
Last Update Posted:
2008-12-30
First Post:
2005-09-07
Brief Title:
Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan ANRS 1269 TRIVACAN
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 Randomised Controlled Trial Assessing the Efficacy of Two Strategies of Structured Treatment Interruption of Highly Active Antiretroviral Therapy HAART Compared With a Continuous HAART in HIV- Infected Adults in Abidjan
Status:
COMPLETED
Status Verified Date:
2008-12
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:
Interrupting HAART during limited periods of time structured treatment interruption STI could entail benefits better long term tolerance lower drug-induced viral resistance lower cost but also concomitant risks lower efficacy higher drug-induced viral resistance At present the benefitrisk ratio of STI is unclear Several STI trials are in progress in industrialised countries This trial aim at assessing the benefits and risks of two different STI strategies in West Africa
Detailed Description:
The objective of this study is to assess the non-inferiority of two strategies of structured treatment interruption STI of highly active antiretroviral treatment HAART compared with a continuous HAART
Its a multicentric open labeled randomised non-inferiority trial which takes place in 5 health care centres in Abidjan the economic capital city of Cote dIvoire
The trial was designed in two phases
1 Pre-randomisation phase 840 HAART-naive HIV-infected adults start the following continuous HAART regimen zidovudine-lamivudine in combination with
preferably efavirenz for HIV-1 infected men and HIV-1 infected women with an effective contraception and no history of nevirapine-containing p-MTCT prevention of mother to child transmission
ritonavir-indinavir for HIV-2 infected patients women not desiring contraception and women with a past history of p-MTCT with nevirapine
2 Trial phase After at least six months on continuous HAART in the pre-randomisation phase patients who meet success criteria CD4 count over 350mm3 undetectable viral load absence of current opportunistic infection are randomised into three arms
Arm 1 Continuous HAART 1 of 6 patients
Arm 2 Fixed STI strategy 3 of 6 patients immutable periods of 2 months on HAART 4 months off HAART
Arm 3 CD4-guided STI strategy 2 of 6 patients unlimited interruption of HAART and then re-introductionre-interruption guided by the evolution of the CD4 count
Following the DSMB recommendation the arm 3 has been discontinued in october 2005 The trial is continuing for patients in the arms 1 and 2
Its a multicentric open labeled randomised non-inferiority trial which takes place in 5 health care centres in Abidjan the economic capital city of Cote dIvoire
The trial was designed in two phases
1 Pre-randomisation phase 840 HAART-naive HIV-infected adults start the following continuous HAART regimen zidovudine-lamivudine in combination with
preferably efavirenz for HIV-1 infected men and HIV-1 infected women with an effective contraception and no history of nevirapine-containing p-MTCT prevention of mother to child transmission
ritonavir-indinavir for HIV-2 infected patients women not desiring contraception and women with a past history of p-MTCT with nevirapine
2 Trial phase After at least six months on continuous HAART in the pre-randomisation phase patients who meet success criteria CD4 count over 350mm3 undetectable viral load absence of current opportunistic infection are randomised into three arms
Arm 1 Continuous HAART 1 of 6 patients
Arm 2 Fixed STI strategy 3 of 6 patients immutable periods of 2 months on HAART 4 months off HAART
Arm 3 CD4-guided STI strategy 2 of 6 patients unlimited interruption of HAART and then re-introductionre-interruption guided by the evolution of the CD4 count
Following the DSMB recommendation the arm 3 has been discontinued in october 2005 The trial is continuing for patients in the arms 1 and 2
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