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- 14-12-22 - 6 Formulieren, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Eric O. Johnson, PhD, RTI International, Research Triangle Park, North Carolina, USA MeSH: HIV,Viral Load,Substance Abuse, intravenous https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000454 The overarching goal of this project is to identify and characterize genetic determinants of HIV 1 susceptibility and resistance in samples of African American (AA) and European American (EA) injection drug users (IDUs) by conducting (1) a case/control genome-wide association (GWA) study of HIV 1 infection (positive/negative); (2) a case-only GWA study of viral load among HIV+ IDUs. The study uses existing samples and data from Urban Health Study (UHS) (PI: Alex Kral), which was the longest-running study of street-recruited IDUs in North America, from 1986-2005. UHS was a serial, cross-sectional sero-epidemiological study. Data were collected every 6 months in communities with a high prevalence of injection drug use in the San Francisco Bay Area. It used targeted sampling in neighborhoods at easily accessible community field sites, such as churches, single room occupancy hotels, and community centers. Eligibility criteria for initial entry to the study were (1) injection drug use in past 30 days; (2) ability to provide informed consent; and (3) age 18 or older. The UHS cohort includes over 9,000 African American and European American IDUs whose serum samples have been stored and data are available on HIV antibody status, HIV risk behaviors, drug abuse and demographics. The current study includes 984 HIV+ cases and 2,243 HIV- controls. Approximately two HIV- controls per case were frequency matched on: (1) self-reported ancestry; (2) sex; (3) age; (4) year of ascertainment; and (5) HIV risk class. This GWAS (DA026141) was funded by the National Institute on Drug Abuse (NIDA; PI: Eric O. Johnson). Funding support for genotyping, which was performed at the Johns Hopkins University Center for Inherited Disease Research (CIDR), was provided by NIDA and the NIH contract "High throughput genotyping for studying the genetic contributions to human disease"(HHSN268200782096C).

pht002648.v1.p1

1 Itemgroep 4 Data-elementen

pht002649.v1.p1

1 Itemgroep 5 Data-elementen

pht002650.v1.p1

1 Itemgroep 23 Data-elementen

pht003326.v1.p1

1 Itemgroep 5 Data-elementen

pht003327.v1.p1

1 Itemgroep 5 Data-elementen
- 13-12-22 - 5 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: pht002506
Principal Investigator: James J. Goedert, M.D., National Institutes of Health, Bethesda, MD, USA MeSH: HIV,Hemophilia A https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000445 Rare individuals are highly resistant to infection with human immunodeficiency virus (HIV). Studies of candidate genes resulted in the discovery of a 32bp deletion in the CC-chemokine receptor 5 gene (CCR5Δ32), which rendered this critical co-receptor for primary HIV infection to be non-functional. Pharmacologic and vaccine-induced blockade of CCR5 is being pursued to treat and prevent HIV infection and other conditions. The allele frequency of CCR5Δ32 among persons of European ancestry is approximately 10%. CCR5Δ32/Δ32 homozygotes are almost totally resistant to HIV infection. People with severe hemophilia A require frequent replacement with clotting Factor VIII (FVIII) to control hemorrhage. Prior to the discovery of HIV in 1984 and licensure of recombinant FVIII in the late 1980s, people with severe hemophilia A were treated with plasma-derived FVIII and thus were intensively exposed to HIV. Only 5% of such patients were not infected with HIV. Of these, approximately 1/3 were CCR5Δ32/Δ32 homozygotes. The remaining 2/3 of these people who were highly resistant to HIV remain unexplained. This project seeks to discover genome variations among people who are highly resistant to HIV infection. Such variation is likely to serve as a target for reducing the morbidity and incidence of HIV.

pht002507.v1.p1

1 Itemgroep 5 Data-elementen

pht002504.v1.p1

1 Itemgroep 3 Data-elementen

pht002505.v1.p1

1 Itemgroep 3 Data-elementen

Eligibility

1 Itemgroep 1 Data-element
- 12-10-22 - 5 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: pht002504
Principal Investigator: James J. Goedert, M.D., National Institutes of Health, Bethesda, MD, USA MeSH: HIV,Hemophilia A https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000445 Rare individuals are highly resistant to infection with human immunodeficiency virus (HIV). Studies of candidate genes resulted in the discovery of a 32bp deletion in the CC-chemokine receptor 5 gene (CCR5Δ32), which rendered this critical co-receptor for primary HIV infection to be non-functional. Pharmacologic and vaccine-induced blockade of CCR5 is being pursued to treat and prevent HIV infection and other conditions. The allele frequency of CCR5Δ32 among persons of European ancestry is approximately 10%. CCR5Δ32/Δ32 homozygotes are almost totally resistant to HIV infection. People with severe hemophilia A require frequent replacement with clotting Factor VIII (FVIII) to control hemorrhage. Prior to the discovery of HIV in 1984 and licensure of recombinant FVIII in the late 1980s, people with severe hemophilia A were treated with plasma-derived FVIII and thus were intensively exposed to HIV. Only 5% of such patients were not infected with HIV. Of these, approximately 1/3 were CCR5Δ32/Δ32 homozygotes. The remaining 2/3 of these people who were highly resistant to HIV remain unexplained. This project seeks to discover genome variations among people who are highly resistant to HIV infection. Such variation is likely to serve as a target for reducing the morbidity and incidence of HIV.

pht002505.v1.p1

1 Itemgroep 3 Data-elementen

pht002506.v1.p1

1 Itemgroep 3 Data-elementen

pht002507.v1.p1

1 Itemgroep 5 Data-elementen

Eligibility

1 Itemgroep 1 Data-element
- 27-09-21 - 1 Formulier, 6 Itemgroepen, 45 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Clinical HIV staging, HIV infection WHO clinical stage 1, HIV infection WHO clinical stage 2, HIV infection WHO clinical stage 3, HIV infection WHO clinical stage 4
Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form is used for recording clinical symptoms of HIV as well as staging the disease, is only applicable to HIV-positive infants and is to be filled in at Visits 1, 5, 8 and 10.
- 20-09-21 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 2 Talen
Itemgroepen: Inclusion Criteria, Exclusion Criteria
- 20-09-21 - 1 Formulier, 2 Itemgroepen, 26 Data-elementen, 2 Talen
Itemgroepen: Inclusion Criteria, Exclusion Criteria
- 20-09-21 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 2 Talen
Itemgroepen: Inclusion Criteria, Exclusion Criteria
- 24-04-21 - 1 Formulier, 13 Itemgroepen, 55 Data-elementen, 1 Taal
Itemgroepen: HIV transmission risk, Current antiretroviral therapy, Antiretroviral therapy duration before SARS-CoV-2 detection, Antiretroviral therapy changed / started during SARS-Cov-2 infection, Antiretroviral therapy regimen at end of follow-up period, CD4+ T-cell count (abs.), CD4+ T-cell count (rel.), HIV CDC stage at baseline, CD8+ T-cell count (abs.), CD8+ T-cell count (rel.), HIV viral load, Opportunistic infections, AIDS-defining illnesses, STI during COVID-19, Is data entry for this section finished?
- 09-04-21 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 2 Talen
Itemgroepen: Inclusion Criteria, Exclusion Criteria

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