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

NCT00337181 | Completed Results

• 2 other identifiers: A-11048RV152
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV-1

Keywords

HIV-1; Natural History; HIV vaccine; Thailand

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reaching Clinical Long Term Component Endpoints

  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

  66 months

Study Arms (2)

Vaccine Group

Received vaccination in RV144

Placebo Group

Received placebo in RV144

Eligibility Criteria

• Age: 18 Years - 31 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All individuals who became HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one injection

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Royal Thai Ministry of Public Health: collaborator
• Mahidol University: collaborator
• Armed Forces Research Institute of Medical Sciences, Thailand: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

Chon Buri Regional Hospital

Chon Buri, Chon Buri Province, 20000, Thailand

Location

Related Publications (1)

• 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.

  PMID: 22837492 DERIVED

Limitations and Caveats

A final report can't be located for this protocol. Results were pulled from an abstract that was published after completion. Outcome endpoints in protocol description will not match final outcome measures in results section. AE's can't be located.

Results Point of Contact

• Title: Supachai Rerks-Ngarm
• Organization: Thai Ministry of Public Health

supachai@health.moph.go.th

6629659571

Study Officials

• Supachai Rerks-Ngarm, MD

  Ministry of Health, Thailand

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 15, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 22, 2018
• Results First Posted: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)