HIV Infections Clinical Trial
Official title:
Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
The purpose of this study is to see how HIV reacts in the immune systems of patients who
have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV
drugs in newly infected patients.
Certain populations are good candidates for participation in HIV vaccine trials. These
groups include men who have sex with men, IV drug users, and women at risk of getting HIV
through heterosexual contact. Learning how HIV behaves in these populations once they become
infected can help with the planning of future HIV vaccine studies.
This study provides an opportunity to prospectively monitor markers of HIV infection and
disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in
HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within
study populations over time are important for planning future HIV vaccine trials.
This study consists of two parts. Part A includes HIV-infected patients who enrolled in
HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been
closely monitored and characterized. This study continues to monitor these patients with
follow-up evaluations every 3 months for the first 18 months and then every 6 months
thereafter. Part B includes newly HIV-infected patients. These patients are monitored with
clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6
months through Year 5.
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Observational Model: Case-Only, Time Perspective: Prospective
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