HIV Infections Clinical Trial
Official title:
The Determinants of the Biology of HIV Transmission to Determine the Immunologic and Virologic Characteristics of Those Who May Have Transmitted HIV to Another Individual
The purpose of this study is to look at the amount of HIV in the blood, genital fluid, and
saliva of the partners of patients with early HIV infection. This study will also look at
the strength of the immune systems of patients with early HIV infection.
Because HIV multiplies very quickly in the early stages of infection, patients with early
HIV infection may be more likely to transmit HIV to their partners. The amount of HIV in
blood, genital fluid, and saliva may determine the risk for transmission.
Persons with early HIV infection may represent high transmission risk to their partners.
Early infection, characterized by rapid virologic replication, insufficient immunologic
control of infection, and more rapid course of disease progression, may be associated with
increased infectiousness. The viral determinants of transmission may in part be explained by
viral burden in blood, genital fluids, and oral cavity fluids. All three fluids may be the
source for transmitted virus.
Persons with suspected HIV infection are asked to identify their possible source partners.
The importance of partner referral is emphasized and assisted recruitment or active tracing
is offered if necessary. Source partners will not be approached uninvited. If a partner
states that he/she does not want to be contacted, then he/she will not be contacted further
for the purpose of this study or for any other study. All patients are offered HIV
counseling and plasma testing for HIV-1 RNA and CD4+ cells. Blood specimens are collected
for plasma determination, and cellular and plasma fractions are collected for CAF and
neutralization antibodies. Neutralization assays are used to detect humoral immune response
in patients with primary HIV infection. Genital fluids and saliva are analyzed for viral
RNA. Patients are seen in the clinic on Day 1 for blood draw and return 2 weeks later for
blood test results. A follow-up period of at least 4 weeks is planned. Compensation is
provided to all patients.
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Observational Model: Cohort, Time Perspective: Prospective
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