Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324103
Status:
COMPLETED
Last Update Posted:
2006-05-10
First Post:
2006-05-08
Brief Title:
Structured Treatment Interruptions in Chronic HIV Infection
Sponsor:
Istituto Superiore di SanitÃ
Organization:
Istituto Superiore di SanitÃ
Study Overview
Official Title:
Antiretroviral Treatment With Structured Treatment Interruptions STI Versus Continuous Antiretroviral Treatment in HIV Patients With Persistent Suppression of Viral Replication
Status:
COMPLETED
Status Verified Date:
2005-10
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:
In the last years Structured Treatment Interruptions STI have been proposed to reduce HAART-related toxicity and to increase patients compliance ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication The two arms of the study will be compared in terms of immunological response proportion of patients with CD4500mmc at 2 years
Detailed Description:
Patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen Arm A or to undergo structured treatment interruptions STI Arm B according to the following scheme STIs of 1 1 2 2 and 3 months each followed by a 3-month therapy period
During STIs therapy is resumed in the presence of an HIV-RNA rebound 50000 copiesml or of a CD4 T cell decline 25 of the baseline count 35 for patients with CD4 500mm3 at randomization After the first cycle subsequent STIs are performed only if an HIV-RNA level 400 copiesml is reached after 2 months of therapy resumption
At the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen
Patients are seen at the clinical site every three months for arm A and monthly for arm B On these occasions blood samples are obtained for biochemical and viro-immunological assessments
The toxicity grading scale of the AIDS Clinical Trial Group ACTG is used for the reporting of clinical and laboratory adverse events
In arm B plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension
Patients will discontinue the study in case of early therapy resumption for 2 consecutive times only arm B patients acute retroviral syndrome only for arm B patients AIDS-defining event severe adverse event pregnancy non-compliance patient s request physicians decision
During STIs therapy is resumed in the presence of an HIV-RNA rebound 50000 copiesml or of a CD4 T cell decline 25 of the baseline count 35 for patients with CD4 500mm3 at randomization After the first cycle subsequent STIs are performed only if an HIV-RNA level 400 copiesml is reached after 2 months of therapy resumption
At the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen
Patients are seen at the clinical site every three months for arm A and monthly for arm B On these occasions blood samples are obtained for biochemical and viro-immunological assessments
The toxicity grading scale of the AIDS Clinical Trial Group ACTG is used for the reporting of clinical and laboratory adverse events
In arm B plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension
Patients will discontinue the study in case of early therapy resumption for 2 consecutive times only arm B patients acute retroviral syndrome only for arm B patients AIDS-defining event severe adverse event pregnancy non-compliance patient s request physicians decision
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