HIV Infections Clinical Trial
To assess, in donor-recipient clusters, current models of HIV-1 genetic evolution and pathogenesis, based on the sequence diversity displayed by this lentivirus.
DESIGN NARRATIVE:
Based on anti-HIV-1 screening of a repository of 200,000 blood donor sera collected in late
1984, the Transfusion Safety Study identified and enrolled into ongoing followup 133
seropositive donors and 111 HIV-1-infected transfusion recipients. Included among these were
38 'transmission clusters' composed of a donor and from one to six linked, infected
recipient(s), and, in four cases, infected recipients' sexual partners. Frozen cells and
sera collected at six-month intervals over a six-year period from members of these clusters
were available for study. Specimens were accessed such that sub-repositories of cellular
DNA, PCR-amplified HIV-1 sequences, and viral isolates were generated for future
investigations of these unique clusters. The studies included analysis of sequence diversity
in envelope (env) V3, V4, and V5 hypervariable regions both within each infected individual
over time, and between different members of each cluster and different clusters. Sequence
diversity profiles from PBMC and serum were analyzed separately to discern differences in
these different blood components at each sampling and over time. The pattern of turnover of
specific sequence variants over time (evolution of viral genotypes) was correlated with
clinical and immunological progression.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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