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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01092611
First received: March 22, 2010
Last updated: August 14, 2014
Last verified: August 2014

March 22, 2010
August 14, 2014
March 2010
May 2014   (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 4 years) ] [ Designated as safety issue: No ]
  • CD4 count [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Viral load (VL) and method of measurement [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of HIV disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 4 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 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of specific clinical events and death [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study) [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of potential immune-mediated diseases (pIMDs) [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of SAEs related to study participation [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • 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 ]
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 4 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 4 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 4 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 4 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 4 years) ] [ Designated as safety issue: No ]
  • Antibody concentrations to vaccine antigens [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Cell-mediated immunity responses [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays) [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • 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 ]
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 studies.

General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
AIDS
  • Procedure: Blood collection
    Once a year after Visit 1 (during a maximum of 4 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.
  • Biological: GSK HIV vaccine 732462
    No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
  • Group A
    Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
    Interventions:
    • Procedure: Blood collection
    • Biological: GSK HIV vaccine 732462
  • Group B
    Subjects who were administered placebo in primary studies 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.
 
Completed
190
May 2014
May 2014   (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 previous studies.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Spain
 
NCT01092611
114083, 2009-018097-64
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2014

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