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Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine

This study is currently recruiting participants.
Verified January 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01092611
First received: March 22, 2010
Last updated: February 14, 2013
Last verified: January 2013
History of Changes

March 22, 2010
February 14, 2013
March 2010
December 2017   (final data collection date for primary outcome measure)
  • Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification) [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • CD4 count [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Viral load and method of measurement [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Occurrence of HIV disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Occurrence of each separate defining condition for HIV-disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Occurrence of specific clinical events and death and date [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01092611 on ClinicalTrials.gov Archive Site
  • Time between dose 1 and ART (re)-initiation or ART modification [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and CD4 count measurement [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and VL measurement [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and occurrence of HIV disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Antibody concentrations to vaccine antigens (and date) [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
  • Cell-mediated immunity responses (and date) [ Time Frame: Once a year after Visit 1 (during a maximum of 7 years) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine
Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary study (NCT 00814762).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
HIV Infections
Procedure: Blood collection
Once a year after Visit 1 (during a maximum of 7 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.
  • Group A
    Subjects who were administered the GSK HIV vaccine 732462 in primary study and who accepted to participate in this study
    Intervention: Procedure: Blood collection
  • Group B
    Subjects who were administered placebo in primary study and who accepted to participate in this study
    Intervention: Procedure: Blood collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
213
December 2017
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • HIV-infected subject
  • Previous participation in a study evaluating GSK HIV vaccine 732462
  • Written informed consent obtained from the subject

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Subjects who did not receive a complete vaccination course in the previous study (NCT00814762)
Both
18 Years to 56 Years
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States,   France,   Germany,   Spain
 
NCT01092611
114083
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP