Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411983
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2006-12-14
Brief Title:
A Long-term Follow-up of the HIV-NAT Cohort
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols
Status:
RECRUITING
Status Verified Date:
2024-02
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:
With HIVAIDS increasingly considered a chronic disease 24- or 48-week data from antiretroviral studies are no longer sufficient Only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years Data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached the efficacy of HIV viral load and CD4 cell counts as predictors of disease progression and mortality and the importance of adherence
Detailed Description:
Primary Objective
To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials
Secondary Objective
To Assess
1 Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count andor baseline plasma HIV RNA level
2 Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens NNRTI-based regimens or PI-based regimens
3 Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT nevirapine versus efavirenz and individual PIs IDV SQV Kaletra and atazanavir
4 Resistance profiles in patients on different antiretroviral regimens
5 Long-term consequences of antiretroviral agents on cardiovascular renal hepatic and endocrine function skin gastrointestinal system and urogentital tract
6 Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIVHCV or HIVHBV co-infection
7 Immune recovery syndrome
8 Adherence to different antiretroviral regimens
9 Quality of life
To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials
Secondary Objective
To Assess
1 Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count andor baseline plasma HIV RNA level
2 Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens NNRTI-based regimens or PI-based regimens
3 Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT nevirapine versus efavirenz and individual PIs IDV SQV Kaletra and atazanavir
4 Resistance profiles in patients on different antiretroviral regimens
5 Long-term consequences of antiretroviral agents on cardiovascular renal hepatic and endocrine function skin gastrointestinal system and urogentital tract
6 Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIVHCV or HIVHBV co-infection
7 Immune recovery syndrome
8 Adherence to different antiretroviral regimens
9 Quality of life
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