HIV Diversity and Pathogenesis in Donor-Recipient Clusters

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005360
• Other study ID #: 4247
• Secondary ID: R01HL048367
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: March 15, 2016
• Start date: August 1992
• Est. completion date: July 1997

Study information

• Verified date: December 2001
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1997
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Blood Donors
• Blood Transfusion
• HIV Infections
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

Asher M. Plantar release in the correction of deformities of the foot in childhood. J Bone Joint Surg Am. 1982 Jun;64(5):790-1. — View Citation

Diaz RS, Zhang L, Busch MP, Mosley JW, Mayer A. Divergence of HIV-1 quasispecies in an epidemiologic cluster. AIDS. 1997 Mar 15;11(4):415-22. — View Citation

Sabino EC, Delwart E, Lee TH, Mayer A, Mullins JI, Busch MP. Identification of low-level contamination of blood as basis for detection of human immunodeficiency virus (HIV) DNA in anti-HIV-negative specimens. J Acquir Immune Defic Syndr. 1994 Aug;7(8):853-9. — View Citation