HIV Infections Clinical Trial
Official title:
Virological and Immunological Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa
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.
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 subtypes/geographical 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.
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