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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337181
First Posted: June 15, 2006
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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 (Responsible Party):
U.S. Army Medical Research and Materiel Command
  Purpose
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.

Condition
HIV-1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Estimated Enrollment: 130
Study Start Date: May 2006
Estimated Study Completion Date: June 2017
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 31 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337181


Locations
Thailand
Chon Buri Regional Hospital
Muang District, Chon Buri Province, Thailand, 20000
Sponsors and 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
Investigators
Principal Investigator: Supachai Rerks-Ngarm, MD Ministry of Health, Thailand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00337181     History of Changes
Other Study ID Numbers: A-11048
RV152
CBER BB IND-8795
First Submitted: June 14, 2006
First Posted: June 15, 2006
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by U.S. Army Medical Research and Materiel Command:
HIV-1
Natural History
HIV vaccine
Thailand

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs