Clinical trial NCT01092611: Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine
Official title: Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AIDS
Keywords: long-term follow-up study
HIV-infected subjects
HIV therapeutic vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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

Eligibility 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 previous studies.

Primary outcomes:
measure: Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: CD4 count
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Viral load (VL) and method of measurement
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Occurrence of HIV disease progression
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Occurrence of each separate defining condition for HIV-disease progression
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Occurrence of specific clinical events and death
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: 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)
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Occurrence of potential immune-mediated diseases (pIMDs)
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Occurrence of SAEs related to study participation
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
Secondary outcomes:
measure: Time between dose 1 and ART (re)-initiation or ART modification
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Time between dose 1 and CD4 count measurement
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Time between dose 1 and VL measurement
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Time between dose 1 and occurrence of HIV disease progression
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Antibody concentrations to vaccine antigens
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Cell-mediated immunity responses
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
measure: Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays)
timeFrame: Once a year after Visit 1 (during a maximum of 4 years)
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Camden
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Annandale
country: United States
facility: GSK Investigational Site
state: Virginia
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Bobigny
country: France
facility: GSK Investigational Site
city: Créteil
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Paris Cedex 10
country: France
facility: GSK Investigational Site
city: Paris Cedex 12
country: France
facility: GSK Investigational Site
city: Paris Cedex 13
country: France
facility: GSK Investigational Site
city: Paris cedex 15
country: France
facility: GSK Investigational Site
city: Paris Cedex 20
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Móstoles, Madrid
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Harrer T, Dinges W, Roman F; TH-HIV-011 study group. Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30.