Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000932
Status:
COMPLETED
Last Update Posted:
2014-04-15
First Post:
1999-11-02
Brief Title:
A Study of the Long-Term Outcomes of HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Study of Long-Term Clinical Virologic and Immunologic Outcomes in HIV-Infected Individuals
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The purpose of this study is to collect information about life spans and HIV-related illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment experience including no treatment at all
Anti-HIV treatment has been successful in slowing disease progression in many patients However there are still questions regarding the best way to use anti-HIV drugs This study is designed to provide long-term monitoring of patients who have already received anti-HIV treatment as well as patients who are just beginning treatment or have decided not to receive treatment
Anti-HIV treatment has been successful in slowing disease progression in many patients However there are still questions regarding the best way to use anti-HIV drugs This study is designed to provide long-term monitoring of patients who have already received anti-HIV treatment as well as patients who are just beginning treatment or have decided not to receive treatment
Detailed Description:
Highly active antiretroviral therapy HAART often results in short-term benefits for people with HIV in terms of reduced plasma viral levels and increased CD4 cell counts When used at an early stage of HIV disease however the clinical benefit of HAART is uncertain Many questions still remain regarding the optimal use of antiretroviral therapies such as the timing of initial antiretroviral therapy and the composition of the best combination regimen to use initially or after virologic failure Randomized trials of different starting antiretroviral regimens eg FIRST CPCRA 058 different regimens after initial virologic failure eg PIP CPCRA 057 and different management strategies for HIV infection eg bis-POM CPCRA 039 NvR CPCRA 042 GART CPCRA 046 and IL-2 VLDose CPCRA 059 are being conducted by the CPCRA AS PER AMENDMENT 22801 The MDR-HIV CPCRA 064 protocol is now included as an example of a different management strategy for HIV infection whereas the bis-POM CPCRA 039 protocol is no longer included This study provides a mechanism for long-term monitoring of patients enrolled in these trials as well as antiretroviral-naive patients who are either starting treatment or electing to defer treatment
Patients are divided into 3 groups Group A consists of patients currently enrolled in or currently being followed in an ongoing qualifying study see Purpose for CPCRA trials which qualify Group B consists of patients previously enrolled in but not currently being followed in a qualifying study Group C consists of antiretroviral-naive patients not enrolling in a qualifying study ie patients starting treatment outside the FIRST study or patients deferring treatment Patients in Group A undergo monitoring of selected clinical and laboratory parameters including plasma HIV RNA levels and CD4 cell counts once every 4 weeks beginning after completion of all follow-up appointments for all other protocols in which they were enrolled Patients in Groups B and C undergo monitoring of selected clinical and laboratory parameters including plasma HIV RNA levels and CD4 cell counts once every 4 months Patients are followed for at least 5 years AS PER AMENDMENT 22801 Patients who are not being followed in a qualifying protocol and are antiretroviral naive at enrollment or were previously enrolled in the FIRST CPCRA 058 protocol undergo blood draws at enrollment and then annually for measurement of plasma HIV levels by a CPCRA-approved laboratory and future CPCRA-approved HIV-related research Patients who relocate to a non-CPCRA affiliated site are asked to sign a consent for ongoing release every 4 months of their medical records from their new health care provider to the CPCRA
Patients are divided into 3 groups Group A consists of patients currently enrolled in or currently being followed in an ongoing qualifying study see Purpose for CPCRA trials which qualify Group B consists of patients previously enrolled in but not currently being followed in a qualifying study Group C consists of antiretroviral-naive patients not enrolling in a qualifying study ie patients starting treatment outside the FIRST study or patients deferring treatment Patients in Group A undergo monitoring of selected clinical and laboratory parameters including plasma HIV RNA levels and CD4 cell counts once every 4 weeks beginning after completion of all follow-up appointments for all other protocols in which they were enrolled Patients in Groups B and C undergo monitoring of selected clinical and laboratory parameters including plasma HIV RNA levels and CD4 cell counts once every 4 months Patients are followed for at least 5 years AS PER AMENDMENT 22801 Patients who are not being followed in a qualifying protocol and are antiretroviral naive at enrollment or were previously enrolled in the FIRST CPCRA 058 protocol undergo blood draws at enrollment and then annually for measurement of plasma HIV levels by a CPCRA-approved laboratory and future CPCRA-approved HIV-related research Patients who relocate to a non-CPCRA affiliated site are asked to sign a consent for ongoing release every 4 months of their medical records from their new health care provider to the CPCRA
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10110 | REGISTRY | DAIDS ES number | None |