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

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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

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.

Condition or disease
HIV-1

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 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.


Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Cohort
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.
Actual Study Start Date : May 2006
Actual Primary Completion Date : March 1, 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Vaccine Group
Received vaccination in RV144
Placebo Group
Received placebo in RV144



Primary Outcome Measures :
  1. 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



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
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
Criteria

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.

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
Chon Buri, 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
Investigators
Principal Investigator: Supachai Rerks-Ngarm, MD Ministry of Health, Thailand

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 ( Other Identifier: WRAIR )
First Posted: June 15, 2006    Key Record Dates
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018
Last Verified: August 2018
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