Protocol rv 254, search 010
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- 1. STUDY SUMMARY Objectives Primary
- Treatments of subjects who are identified to have acute HIV-infection
- Study design and methodology
- SCHEDULE OF EVENTS Table 1: Recruitment procedures
- Table 2: Follow up of subjects who are confirmed to have acute HIV infection Procedures
- Day 5 Day 7 Day 10 Wk 2 Wk 4
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PROTOCOL RV 254, SEARCH 010 Protocol Title: Establish and characterize an acute HIV infection cohort in a high risk population Version of Protocol/Date of Version: 1.5 dated 25 November 2010 WRAIR Protocol Number: WRAIR # 1494, RV254 Principal Investigator: Jintanat Ananworanich, MD, PhD Department of Retrovirology USAMC-AFRIMS (SEARCH office) 104 Rajdumri Road Pathumwan, Bangkok 10330 Tel 02-254-2566 to 9 Fax 02-254-2567 Email: JintanatA@afrims.org
Nittaya Phanuphak, MD The Thai Red Cross AIDS Research Centre 104 Rajdamri Road, Pathumwan Bangkok, 10330, Thailand Tel: 66 2 253 0996 Fax: 66 2 254 7577 Email: nittaya.p@chula.ac.th Associate Investigators:
Consultant Irini Sereti, MD, MHS NIH/NIAID 10 Center Drive, Building 10, Room 11B07A Phone: 301-496-5533 Fax: 301-402-0497 Medical monitor
Study Location: Thai Red Cross AIDS Research Centre 104 Rajdumri Road, Pathumwan Bangkok, 10330, Thailand Tel: 66 2 253 0996 Fax: 66 2 254 7577
1873 Rama IV, Pathumwan, Bangkok 10330 Tel +66 2 256 4455
Research Section, Faculty of Medicine Chulalongkorn University 1873 Rama IV, Pathumwan, Bangkok 10330 Tel +66 2 256 4455 Ext 14, 15 Walter Reed Army Institute of Research (WRAIR) IRB (FWA00000015) (C/O The Division of Human Subjects Protection) 503 Robert Grant Avenue Silver Spring, MD 20910-7500 University of California at San Francisco (UCSF) IRB (FWA 00000068) Committee on Human Research Office of Research, Suite 315 Box 0962 University of California, San Francisco San Francisco, CA 94118-0962 Tel: (415) 476-1814, fax: (415) 502-1347 Laboratories: Laboratory testing will be done at Dept. of Retrovirology, AFRIMS, The Thai Red Cross AIDS Research Centre (TRCARC), Bangkok, Thailand; the Division of Retrovirology, WRAIR; and WRAIR’s collaborating laboratories [the National Cancer Institute (Frederick, Maryland, USA); the National Institute of Allergy and Infectious Diseases (Bethesda, Maryland, USA) and the Vaccine and Gene Therapy Institute (Port Saint Lucie, Florida, USA)]. Source of Funding: MIDRP Research Area H Task Area 1C Sponsor:
Study Duration: 6 years including at least 6 months of preparation, 48 months (4 years) for recruitment. Each subject will have different lengths of follow up (maximum 48 months and minimum is around 24 months). Anticipated Start Date: April 2009 Anticipated Completion Date (Month and Year): April 2015 Required Number and Type of Study Subjects: We expect to enroll up to 75 subjects aged 18 years and up with acute HIV infection over 4 years. 1. STUDY SUMMARY Objectives Primary: To describe clinical, immunological, and virological characteristics of persons with acute HIV infection Secondary:
Subject population: Male and female clients age 18 years old and up who are seeking VCT at the TRCARC and have a protocol-defined laboratory finding of acute HIV infection (Either negative 4th generation enzyme immunoassay (EIA) and positive HIV nucleic acid (NAT) OR positive 4th generation EIA and negative EIA by a less sensitive method Number of subjects: Approximately 40,000 subjects will be screened to enroll approximately 75 acute HIV infection subjects over 4 years. Treatments of subjects who are identified to have acute HIV-infection: The decision to initiate highly active antiretroviral therapy (HAART) will be up to the subject and his/her physician. Subjects will be referred to the HIV clinic at the TRCARC or other clinics of their choice for routine HIV care. Subjects may be enrolled in other treatment protocols. No modification to follow-up or protocol procedures will be made if subjects choose to receive antiretroviral treatment. Study design and methodology: Subjects will be recruited at the TRCARC (Procedures shown in Table 1). Subjects seeking VCT will be asked to provide contact information (expect 500-800 subjects per month). Blood samples, either plasma or whole blood collected on filter paper (dried blood spots or DBS) will be screened for acute HIV infection by pooled or individual NAT if non-reactive after screening by an EIA capable of detecting both HIV antibody and antigen (4th generation or sensitive EIA). Additionally, 4th generation reactive samples will be screened with a non-IgM sensitive EIA capable of detecting HIV antibody only (less sensitive EIA) within 1-2 days of sample collection. Those who are found to have acute HIV infection will be asked to enroll in the cohort study (Table 2). These acute HIV-infected participants will be followed prospectively at week 0, day 2, 3, 5, 7, 10 then weeks 2, 4, 8, 12, 16, 20, 24, then every 12 weeks until the end of the study (maximum of 192 weeks of follow up). Subjects will receive blood testing for CD4, HIV RNA, ALT, creatinine and lipids, and urinalysis according to Table 2. Subjects will be asked to complete a questionnaire on HIV risk behavior. Neuropsychological assessment, comprehensive neurological examination, psychiatric questionnaires, and assessment of function will be performed. Archiving of plasma and PBMC for future immunologic and virologic testing will be performed by either leukopheresis or phlebotomy for weeks 0, 2, 4, 8, 12, 24, 48 and 96, and by phlebotomy for the remaining study visits). Optional study procedures include 1) collection of genital secretions 2) collection of cerebrospinal fluid 3) brain MRI/MRS without gadolinium 4) sampling of gut-associated lymphoid tissue by colon biopsy 5) genetic testing 6) tracking of and offering VCT to sexual contacts of acute HIV-infected subjects. Subjects are encouraged to be hospitalized for the first 3-7 days for post-procedural observation and for ease of follow up. The total maximum volume of blood is 1,267 ml over 4 years. SCHEDULE OF EVENTS Table 1: Recruitment procedures
Subjects have no obligation to follow any of the study procedures specified above and are able to continue receiving services at the TRCARC without any prejudice towards them.
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