Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113126
Status:
COMPLETED
Last Update Posted:
2006-11-29
First Post:
2005-06-03
Brief Title:
Staccato A Trial of CD4 Guided Treatment Interruption Compared to Continuous Treatment for HIV Infection
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
A Randomized Trial of CD4 Guided Treatment Interruption Compared to Continuous Treatment for HIV Infection
Status:
COMPLETED
Status Verified Date:
2005-06
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 HIV repairs the immune system but continuous treatment is expensive and causes side effects Would it not be better to treat intermittently eg stop treatment when the immune system has recovered and start again only when damage reappears That is the question which STACCATO proposes to answer
Approximately 500 patients were recruited for this trial from 2002 to 2004 One third were treated continuously in two thirds the treatment was interrupted whenever the CD4 count a measure of immune recovery exceeded 350 At the end of 2005 the two treatment groups will be compared in order to see which fared better regarding amount of drugs used side effects CD4 counts and development of resistance to treatment
Approximately 500 patients were recruited for this trial from 2002 to 2004 One third were treated continuously in two thirds the treatment was interrupted whenever the CD4 count a measure of immune recovery exceeded 350 At the end of 2005 the two treatment groups will be compared in order to see which fared better regarding amount of drugs used side effects CD4 counts and development of resistance to treatment
Detailed Description:
Continuous treatment has been very successful in diminishing the diseases and deaths caused by HIV However continuous treatment is expensive Intermittent treatment will always cost less than continuous treatment and therefore has the potential to facilitate access to highly active antiretroviral therapy HAART in developing countries HAART also causes many undesirable effects Intermittent treatment decreases exposure to drugs and is therefore expected to decrease side effects
STACCATO is a randomised trial of intermittent versus continuous anti-retroviral treatment At least 600 patients on HAART with viremia below 50 copiesml and CD4 count above 350 cellsml were randomised to one of two arms in 12 proportions
Arm 1 Continuation control arm Drugs are continued or changed according to current guidelines and good clinical practice
Arm 2 CD4-guided arm Drugs discontinued and reintroduced according to CD4 counts with HAART being administered only if CD4 count is 350 cellsml
Randomized treatment will continue during an average of approximately 2 years and will be followed by a period of 12 to 24 weeks continuous treatment for patients in both arms
Endpoints The amount of drugs used side effects viremia and CD4 counts number of clinical events at the end of the randomized treatment period and again 12 to 24 weeks later A subproject will study the effect of treatment interruption on resistance development mutations in proviral DNA and proviral DNA levels
STACCATO is a randomised trial of intermittent versus continuous anti-retroviral treatment At least 600 patients on HAART with viremia below 50 copiesml and CD4 count above 350 cellsml were randomised to one of two arms in 12 proportions
Arm 1 Continuation control arm Drugs are continued or changed according to current guidelines and good clinical practice
Arm 2 CD4-guided arm Drugs discontinued and reintroduced according to CD4 counts with HAART being administered only if CD4 count is 350 cellsml
Randomized treatment will continue during an average of approximately 2 years and will be followed by a period of 12 to 24 weeks continuous treatment for patients in both arms
Endpoints The amount of drugs used side effects viremia and CD4 counts number of clinical events at the end of the randomized treatment period and again 12 to 24 weeks later A subproject will study the effect of treatment interruption on resistance development mutations in proviral DNA and proviral DNA levels
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