HIV Diversity and Pathogenesis in Donor-Recipient Clusters

NCT ID: NCT00005360

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1992-08-31

Study Completion Date

1997-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acquired Immunodeficiency Syndrome Blood Transfusion Blood Donors HIV Infections

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

No eligibility criteria
Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

References

Explore related publications, articles, or registry entries linked to this study.

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. No abstract available.

Reference Type BACKGROUND
PMID: 7085708 (View on PubMed)

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. doi: 10.1097/00002030-199704000-00003.

Reference Type BACKGROUND
PMID: 9084787 (View on PubMed)

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 (1988). 1994 Aug;7(8):853-9.

Reference Type BACKGROUND
PMID: 8021818 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL048367

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4247

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Biology of HIV Transmission
NCT00001092 COMPLETED
HIV-Associated Heart Disease
NCT00005229 COMPLETED
Transfusion Safety Study (TSS)
NCT00005301 COMPLETED
HIV and Cardiovascular Risk
NCT00465426 COMPLETED
HLA-B35 Alleles and AIDS
NCT00340223 WITHDRAWN