ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00337181
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
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
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

June 14, 2006
June 15, 2006
December 6, 2017
August 22, 2018
August 22, 2018
May 2006
March 1, 2011   (Final data collection date for primary outcome measure)
Number of Participants Reaching Clinical Long Term Component Endpoints [ Time Frame: 66 months ]
Evaluate the vaccine effect on clinical long term endpoints: CD4 is for CD4<350 endpoint; ART is for initiation of highly-active antiretroviral therapy (HAART) endpoint; ADI is for AIDS-defining illness endpoint; A combination of multiple endpoints is listed in order of occurrences of the endpoints
Not Provided
Complete list of historical versions of study NCT00337181 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 in reference to study NCT00223080 RV144. 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 in reference to study NCT00223080 RV144. 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.

After enrollment in RV152, follow-up visits were scheduled at 0, 1, 3, and 6 months, and every 3 months thereafter. After month 12, CD4+ T cell counts and viral load were obtained at 6-month intervals until the CD4+ T cell count declined to <350/ul or highly-active antiretroviral therapy (HAART) was initiated, at which time CD4+ T cell counts and viral load were obtained every 3 months. Peripartum antiretroviral drugs given for prevention of mother-to-child-transmission was not considered a study endpoint, however HAART initiated during pregnancy and continued post-partum was counted. After a single CD4+ T-cell count < 350/ul a second sample was requested about 2 weeks later, and if the confirmatory measurement was >350/ul, a study endpoint was not registered and the volunteer resumed a normal visit schedule. A single genital fluid collection for viral load was obtained at the first RV152 visit. Clinical and laboratory data from RV144, including CD4+ T-cell and HIV-1 plasma viral load measurements, were linked to RV152 to inform primary and secondary protocol analyses as well as volunteer care and treatment.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
All individuals who became HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one injection
HIV-1
Not Provided
  • Vaccine Group
    Received vaccination in RV144
  • Placebo Group
    Received placebo in RV144
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.
 
Completed
114
130
June 2011
March 1, 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All individuals who become HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one 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.
Sexes Eligible for Study: All
18 Years to 31 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT00337181
A-11048
RV152 ( Other Identifier: WRAIR )
No
Not Provided
Plan to Share IPD: No
U.S. Army Medical Research and Materiel Command
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
Principal Investigator: Supachai Rerks-Ngarm, MD Ministry of Health, Thailand
U.S. Army Medical Research and Materiel Command
August 2018