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

Purpose

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).

Condition	Intervention	Phase
HIV Infections	Procedure: Blood collection	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title:	Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	213
Study Start Date:	March 2010
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A Subjects who were administered the GSK HIV vaccine 732462 in primary study and who accepted to participate in this study	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 B Subjects who were administered placebo in primary study and who accepted to participate in this study	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.

Eligibility

Ages Eligible for Study:	18 Years to 56 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092611

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Show 41 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01092611 History of Changes
Other Study ID Numbers:	114083
Study First Received:	March 22, 2010
Last Updated:	February 14, 2013
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

long-term follow-up study
HIV-infected subjects
HIV therapeutic vaccine

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013