Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005360
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
HIV Diversity and Pathogenesis in Donor-Recipient Clusters
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
To assess in donor-recipient clusters current models of HIV-1 genetic evolution and pathogenesis based on the sequence diversity displayed by this lentivirus
Detailed Description:
DESIGN NARRATIVE
Based on anti-HIV-1 screening of a repository of 200000 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 recipients 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
Based on anti-HIV-1 screening of a repository of 200000 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 recipients 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
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL048367 | NIH | None | httpsreporternihgovquickSearchR01HL048367 |