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Catalogue of Clinical Trials and Cohort Studies to Identify Biological Catalogue of clinical trials and cohort studies to identify biological specimens of relevance to the development of assays for acute and early HIV infection: Final Report Catalogue of clinical trials and cohort studies to identify biological specimens of relevance to the development of assays for recent HIV infection Final Report February 2010 This final report was prepared by Dr Joanne Micallef and Professor John Kaldor, The University of New South Wales, under subcontract with Family Health International, funded by the Bill and Melinda Gates Foundation under the grant titled “Development of Assays for Acute HIV Infection and Estimation and HIV Incidence in Population”. 1 Catalogue of clinical trials and cohort studies to identify biological specimens of relevance to the development of assays for acute and early HIV infection: Final Report Table of Contents Table of Contents .................................................................................................................................................................... 2 List of acronyms ...................................................................................................................................................................... 4 1 Introduction ..................................................................................................................................................................... 6 2 Methods ............................................................................................................................................................................. 7 2.1 Identification of potential studies and sample sets of relevance to the development and evaluation of assays for recent HIV infection ......................................................................................................... 7 2.1.1 Sources of sample sets .................................................................................................................................. 7 2.1.2 Literature search ............................................................................................................................................. 8 2.2 Survey of study investigators ......................................................................................................................... 9 2.2.1 Initial contact with study investigators ................................................................................................. 9 2.2.2 Follow up of study investigators ............................................................................................................ 10 2.2.3 Questionnaire sent to study investigators ......................................................................................... 10 2.2.4 Analysis of findings ...................................................................................................................................... 11 2.2.5 Data management ......................................................................................................................................... 12 3 Results and Discussion .............................................................................................................................................. 17 3.1 Literature search................................................................................................................................................ 17 3.1.1 Seronegative cohorts ................................................................................................................................... 17 3.1.2 Acute cohorts .................................................................................................................................................. 19 3.2 Contact with study investigators ................................................................................................................ 20 3.2.1 Response to letter and questionnaire: Seronegative cohorts .................................................... 20 3.2.2 Response to letter and questionnaire: Acute cohorts .................................................................... 22 3.3 Survey results: Seronegative cohorts ........................................................................................................ 23 3.3.1 Summary of study details .......................................................................................................................... 23 3.3.2 Information about the biological specimens ..................................................................................... 24 3.3.3 Availability of the specimens ................................................................................................................... 24 3.4 Survey results: Acute cohorts ....................................................................................................................... 28 2 Catalogue of clinical trials and cohort studies to identify biological specimens of relevance to the development of assays for acute and early HIV infection: Final Report 3.4.1 Summary of study details .......................................................................................................................... 28 3.4.2 Information about the biological specimens ..................................................................................... 28 3.4.3 Availability of the specimens ................................................................................................................... 29 3.4.4 Suitability of specimens identified to be included in sample panels ....................................... 33 4 Discussion ....................................................................................................................................................................... 37 Appendices .............................................................................................................................................................................. 40 References ................................................................................................................................................................................ 61 3 Catalogue of clinical trials and cohort studies to identify biological specimens of relevance to the development of assays for acute and early HIV infection: Final Report List of acronyms AIDS Acquired immune deficiency syndrome ALIVE AIDS Linked to Intravenous Experience ANRS French National Agency for Research on AIDS and Viral Hepatitis BREC Biomedical Research Ethics Committee CAPRISA Centre for the AIDS Programme of Research in South Africa CDC Centers for Disease Control and Prevention CRF Circulating Recombinant Forms FRR False recent rate FRSQ Fonds de la recherche en santé du Québec HIV Human immunodeficiency virus HIV-1 Human immunodeficiency virus subtype 1 HPTN HIV Prevention Trials Network IAVI International AIDS Vaccine Initiative IDU Injecting Drug Use IRB Institutional Review Board MSM Men who have sex with men NCAIDS National Center for AIDS/STD Prevention and Control PBMCs Peripheral Blood Mononuclear Cells PHI Primary HIV Infection RCT Randomised Clinical Trial 4 Catalogue of clinical trials and cohort studies to identify biological specimens of relevance to the development of assays for acute and early HIV infection: Final Report RIS la Red de Investigación en Sida (the Network of Investigation into AIDS) RITA recent infection testing algorithm US United States WHO World Health Organisation 5 Catalogue of clinical trials and cohort studies to identify biological specimens of relevance to the development of assays for acute and early HIV infection: Final Report 1 Introduction Reliable estimates of the incidence of HIV infection in populations are crucial for describing the status of HIV epidemics, monitoring transmission patterns, evaluating prevention programs and the planning and evaluation of intervention programs. Assays for recent HIV infection are capable of distinguishing recent from non-recent HIV infections, and therefore able to measure HIV incidence in populations using cross-sectional study methods. Assays for recent HIV infection are based on the underlying principle that the immunologic response to HIV infection evolves for a number of months following infection and the capability to measure some aspect of this evolution. Several assays for recent infection have been developed since the first in 1998 and have been used to estimate incidence in a range of surveillance and research settings. The use of current assays for recent infection to estimate HIV incidence is challenged by various obstacles such as: 1. The variability of the immune response among HIV-1 infected individuals, the impact of use of antiretroviral therapy and late stage immunosuppression, resulting in reduced sensitivity and specificity, 2. Mean recent infection testing algorithm (RITA) duration variability among various HIV-1 subtypes and populations, 3. Lack of standardization to calibrate and validate assays for recent infection, 4. Inconsistent commercial availability of HIV diagnostic assays which serve as the foundation for a number of assays for recent infection, 5. Complex laboratory methods and high cost of assays and 6. Inconsistent methodologies for the use of assays to estimate HIV infection. An essential element of the development and evaluation process for the calibration and validation of assays for recent infection is the availability of relevant biological sample sets. The objective
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