Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219934
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2005-09-20
Brief Title:
Observational Study of Treated and Untreated Acute and Early HIV-1 Infection
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
Observational Study of Treated and Untreated Acute and Early HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2012-02
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:
Group A Long-term follow-up is needed for subjects identified as acute or early in the course of HIV-1 infection independent of decisions regarding therapy with highly active anti-retroviral therapy HAART
Group B This protocol will also be offered to subjects who were diagnosed with acute HIV-1 infection in the past and have been participating in an ADARCRockefeller University Hospital treatment protocol for acute HIV-1 infection and currently have a viral load consistently less than 50 copiesml on current treatment Group B
Group B This protocol will also be offered to subjects who were diagnosed with acute HIV-1 infection in the past and have been participating in an ADARCRockefeller University Hospital treatment protocol for acute HIV-1 infection and currently have a viral load consistently less than 50 copiesml on current treatment Group B
Detailed Description:
At the initial visit subjects will undergo a complete history and physical examination They will have blood drawn for HIV-1 antibody testing resistance testing and lymphocyte subsets In addition blood will be drawn for hematology chemistries and syphilis and Hepatitis B and C serologies
Individuals in Group B will not have HIV-1 antibody testing resistance testing or Hepatitis B and C serologies performed as these would have been performed as part of their current protocol Individuals electing to initiate antiretroviral therapy will obtain standard HAART as prescribed by their physicians
Group A subjects will be seen at Weeks 4 and 12 then every 12 weeks until week 48 then every 24 weeks until week 96 If treated during acute and early infection then they will be seen every 48 weeks thereafter for 5 years If untreated during acute and early infection then they will be discontinued from the study
Group B participants who have been followed for less than 96 weeks will be seen every 12 weeks until week 48 then every 24 weeks until week 96
Participants currently enrolled beyond week 96 who were treated during acute and early infection and whose treatment was uninterrupted will be seen every 48 weeks If participants were not treated during acute and early infection or treatment was interrupted then they will be discontinued from the study
Individuals in Group B will not have HIV-1 antibody testing resistance testing or Hepatitis B and C serologies performed as these would have been performed as part of their current protocol Individuals electing to initiate antiretroviral therapy will obtain standard HAART as prescribed by their physicians
Group A subjects will be seen at Weeks 4 and 12 then every 12 weeks until week 48 then every 24 weeks until week 96 If treated during acute and early infection then they will be seen every 48 weeks thereafter for 5 years If untreated during acute and early infection then they will be discontinued from the study
Group B participants who have been followed for less than 96 weeks will be seen every 12 weeks until week 48 then every 24 weeks until week 96
Participants currently enrolled beyond week 96 who were treated during acute and early infection and whose treatment was uninterrupted will be seen every 48 weeks If participants were not treated during acute and early infection or treatment was interrupted then they will be discontinued from 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