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

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

This study is currently recruiting participants.
Verified by Walter Reed Army Institute of Research (WRAIR), June 2007

Sponsors and Collaborators:	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 sanofi pasteur VaxGen
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00337181

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	Intervention
HIV-1	Biological: ALVAC-HIV (vCP1521), sanofi pasteur Biological: AIDSVAX B/E: Bivalent HIV gp120

MedlinePlus related topics:

AIDS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study

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.

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Estimated Enrollment:	130
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2013

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

Ages Eligible for Study:	18 Years to 31 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337181

Contacts


Contact: Supachai Rerks-Ngarm, MD	6629659571	Supachai@health.moph.go.th

Locations


Thailand, Chon Buri Province
	Chon Buri Regional Hospital	Recruiting
	Muang District, Chon Buri Province, Thailand, 20000
	Contact: Chureeratana Bowonwatanuwong, MD 638-285-5229 Cbonwon@Chonburi.KSC.co.TH
	Contact: Narongsak Ekwattanakul, MD 638-426-730
	Sub-Investigator: Supamit Chunsutthiwat, MD, MPH
	Sub-Investigator: COL Sorachai Nitayaphan, MD, PhD
	Sub-Investigator: Jaranit Kaewkungwal, PhD
	Sub-Investigator: MAJ Robert Paris, MD, MPH
	Sub-Investigator: Mark de Souza, PhD, PMP
	Sub-Investigator: LTC Jerome Kim, MD
	Principal Investigator: Supachai Rerks-Ngarm, MD

Sponsors and Collaborators

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

sanofi pasteur

VaxGen

Investigators


Principal Investigator:	Supachai Rerks-Ngarm, MD	Thai Ministry of Public Health

More Information

Study ID Numbers:	WRAIR 1184, RV152, CBER BB IND-8795
First Received:	June 14, 2006
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00337181
Health Authority:	United States: Office of the Surgeon General; United States: US Medical Materiel Agency; United States: Federal Government

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

HIV-1

Natural History

HIV vaccine

Thailand

Study placed in the following topic categories:

HIV Infections

Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on September 23, 2008