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Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Walter Reed Army Institute of Research (WRAIR).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Royal Thai Ministry of Public Health
Mahidol University
Armed Forces Research Institute of Medical Sciences, Thailand
Sanofi Pasteur, a Sanofi Company
Global Solutions for Infectious Diseases
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00337181
First received: June 14, 2006
Last updated: June 2, 2010
Last verified: June 2010
History of Changes

June 14, 2006
June 2, 2010
May 2006
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Complete list of historical versions of study NCT00337181 on ClinicalTrials.gov Archive Site
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Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
Extended Evaluation of the Virologic, Immunologic, and Clinical Course of Volunteers Who Become HIV-1 Infected During Participation in a Phase III Vaccine Trial of ALVAC-HIV and AIDSVAX® B/E.

This protocol will study the clinical course of HIV-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and AIDSVAX B/E prior to HIV-1 infection. The study will assess whether those who received the experimental vaccine combination have a slower progression of HIV disease compared to those who received the placebo injection.

Prospective cohort study of the clinical course of HIV-1 infection occurring after candidate HIV-1 vaccination (breakthrough infection) with ALVAC-HIV (vcP1521) and AIDSVAX B/E. This study will enroll volunteers who become HIV-infected during the course of follow up in a phase III preventive HIV vaccine trial conducted in Rayong and Chon Buri, Thailand. Volunteers will be enrolled in this protocol to provide additional long-term follow up to establish whether differences in viral load after infection (comparing vaccine to placebo) are associated with altered disease outcomes, as well as provide more detailed immunologic and virologic assessment of these volunteers.
Observational
Time Perspective: Prospective
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HIV-1
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Rerks-Ngarm S, Paris RM, Chunsutthiwat S, Premsri N, Namwat C, Bowonwatanuwong C, Li SS, Kaewkungkal J, Trichavaroj R, Churikanont N, de Souza MS, Andrews C, Francis D, Adams E, Flores J, Gurunathan S, Tartaglia J, O'Connell RJ, Eamsila C, Nitayaphan S, Ngauy V, Thongcharoen P, Kunasol P, Michael NL, Robb ML, Gilbert PB, Kim JH. Extended evaluation of the virologic, immunologic, and clinical course of volunteers who acquired HIV-1 infection in a phase III vaccine trial of ALVAC-HIV and AIDSVAX B/E. J Infect Dis. 2013 Apr 15;207(8):1195-205. doi: 10.1093/infdis/jis478. Epub 2012 Jul 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
May 2013
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Inclusion Criteria:

  • All individuals who become HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical tria if they received at least injection.
  • The volunteer must give written, informed consent.

Exclusion Criteria:

  • Persons who have a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
  • Persons who become HIV-infected after the completion of the RV144 protocol.
Both
18 Years to 31 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00337181
WRAIR 1184, RV152, CBER BB IND-8795
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U.S. Army Office of the Surgeon General
  • U.S. Army Medical Research and Materiel Command
  • Walter Reed Army Institute of Research (WRAIR)
  • Royal Thai Ministry of Public Health
  • Mahidol University
  • Armed Forces Research Institute of Medical Sciences, Thailand
  • Sanofi Pasteur, a Sanofi Company
  • Global Solutions for Infectious Diseases
Principal Investigator: Supachai Rerks-Ngarm, MD Ministry of Health, Thailand
Walter Reed Army Institute of Research (WRAIR)
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP