Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068809
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2003-09-10
Brief Title:
4-Day-A-Week Treatment Plan for HIV Infected Adolescents
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Short-Cycle Therapy in Adolescents Following Continuous Therapy With Established Viral Suppression The Impact on Viral Load Suppression
Status:
COMPLETED
Status Verified Date:
2016-02
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:
This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral replication in patients who have already had at least 6 months of documented viral suppression with full-time treatment If this strategy is shown to be safe in this study a larger study will be undertaken to determine if the strategy can decrease overall drug exposure and help young people adjust more easily to a chronic medication schedule
Detailed Description:
HIV infected adolescents who require therapy face a lifetime of antiretroviral treatment Highly active antiretroviral therapy HAART is associated with short- and long-term complications and concerns are mounting about the cumulative effect of these complications as adolescents enter the third and fourth decade of life A management strategy that can suppress the virus and decrease overall drug exposure is needed In addition the scheduling requirements for antiretroviral therapies interfere with the socialization and independence that an adolescent must accomplish to gain skills for a successful adult life Not surprisingly nonadherence to prescribed medications is common in teens This multicenter prospective proof of concept trial will evaluate Short Cycle Therapy SCT in adolescents with sustained viral suppression of at least 6 months While maintenance of viral load suppression can be viewed as either a safety or efficacy endpoint the trial is constructed as an assessment of safety
Eligible participants who have been on standard HAART therapy consisting of a Protease Inhibitor will switch to SCT therapy4 days on treatment 3 days off treatment each week at entry Participants will be seen in the clinic every other Monday during the first month then monthly up to 24-weeks and then once every two months until the end of the 48-week study period Plasma HIV RNA levels and CD4 cell counts will be performed at every visit Medication adherence by self-report will be conducted every 2 weeks until week 24 and every 4-weeks thereafter until week 48 Fasting serum triglycerides and cholesterol will be measured at baseline at week 24 and at the end of the study
Eligible participants who have been on standard HAART therapy consisting of a Protease Inhibitor will switch to SCT therapy4 days on treatment 3 days off treatment each week at entry Participants will be seen in the clinic every other Monday during the first month then monthly up to 24-weeks and then once every two months until the end of the 48-week study period Plasma HIV RNA levels and CD4 cell counts will be performed at every visit Medication adherence by self-report will be conducted every 2 weeks until week 24 and every 4-weeks thereafter until week 48 Fasting serum triglycerides and cholesterol will be measured at baseline at week 24 and at the end of the study
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