Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006298
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2000-09-26
Brief Title:
Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Virological and Immunological Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa
Status:
COMPLETED
Status Verified Date:
2004-07
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 main goal of this study is to find out how the immune system responds to a specific type of HIV infection known as C HIV-1 in order to develop a vaccine against this type of infection The study involves Southern African populations
The HIV-1 virus changes rapidly and many different subtypes have been found In South Africa limited data have suggested Subtype C HIV-1 is the most common This study strives to verify the most common subtype and also look at genetic differences and immune responses among newly infected individuals Results will aid in the development of vaccines specific for certain geographical areas
The HIV-1 virus changes rapidly and many different subtypes have been found In South Africa limited data have suggested Subtype C HIV-1 is the most common This study strives to verify the most common subtype and also look at genetic differences and immune responses among newly infected individuals Results will aid in the development of vaccines specific for certain geographical areas
Detailed Description:
HIV-1 evolves rapidly and multiple genetic subtypes have been isolated from a number of geographic locations There are limited data on the distribution of subtypes in the Southern African HIVNET sites Data suggest subtype C HIV-1 predominates and this study is designed to substantiate and extend these observations to understand the biological relationship between HIV-1 subtypes genetic variability and immune responses Earlier studies were conducted using individuals who had been seropositive for 3 to 9 years with advanced disease status this study will test reactivity during the early stage of infection This will assist in the rational selection of prototypic isolates for inclusion in either a single universal vaccine or vaccines tailored for specific subtypesgeographical regions
Volunteers are recruited from Malawi South Africa Zambia and Zimbabwe The earliest possible cases of seroconversion are included At enrollment participants are counseled appropriately for their HIV status and demographic information is obtained Participants are followed quarterly up to 12 months Epidemiological clinical and laboratory data are collected during physical exams and blood draws at each visit Blood samples are used to assess CD4 counts plasma viral load genetic parameters and individual immune responses Participants who are seronegative or whose status is unknown are tested for HIV at each visit with post-test counseling when participants return to the clinic for test results
In addition to enrolling the HIV-infected and uninfected volunteers each site contributes a 5-ml blood sample from 50 seronegative individuals for DNA extraction and HLA genotyping
Volunteers are recruited from Malawi South Africa Zambia and Zimbabwe The earliest possible cases of seroconversion are included At enrollment participants are counseled appropriately for their HIV status and demographic information is obtained Participants are followed quarterly up to 12 months Epidemiological clinical and laboratory data are collected during physical exams and blood draws at each visit Blood samples are used to assess CD4 counts plasma viral load genetic parameters and individual immune responses Participants who are seronegative or whose status is unknown are tested for HIV at each visit with post-test counseling when participants return to the clinic for test results
In addition to enrolling the HIV-infected and uninfected volunteers each site contributes a 5-ml blood sample from 50 seronegative individuals for DNA extraction and HLA genotyping
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: