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AIDSPhase 1NCT01092611

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

A Phase 1 study testing Blood collection and GSK HIV vaccine 732462 in people with AIDS, run by GlaxoSmithKline at 41 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
AIDS
What is being tested?
Blood collection and GSK HIV vaccine 732462
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
41 sitesin 4 countries
Study dates
22 Mar 2010to 19 May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

41 sites in 4 countries.

41 sites in 4 countries

Germany13 sites

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44791

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Erlangen, Bavaria, 91054

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Hamburg, 20095

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Munich, Bavaria, 80335

  • GSK Investigational Site

    Munich, Bavaria, 80801

  • GSK Investigational Site

    Munich, Bavaria, 81371

Other trials in Germany

United States11 sites

  • GSK Investigational Site

    Annandale, Virginia, 22003

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Camden, New Jersey, 08103

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33308

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Seattle, Washington, 98104

Other trials in United States

France10 sites

  • GSK Investigational Site

    Bobigny, 93009

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Paris, 75571

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Paris, 75679

  • GSK Investigational Site

    Paris, 75908

  • GSK Investigational Site

    Paris, 75970

Other trials in France

Spain7 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Móstoles, Madrid, 28935

  • GSK Investigational Site

    Valencia, 46014

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
AIDS
Being tested
Blood collection, GSK HIV vaccine 732462
Keywords
long-term follow-up study, HIV-infected subjects, HIV therapeutic vaccine
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood collectionProcedure or surgery

    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.

  • GSK HIV vaccine 732462Biological

    No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.

Study groups in NCT01092611
Study groupRoleWhat they receive
Group AOtherSubjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
Receives: Procedure: Blood collection; Biological: GSK HIV vaccine 732462
Group BOtherSubjects who were administered placebo in primary studies and who accepted to participate in this study
Receives: Procedure: Blood collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  2. CD4 count

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  3. Viral load (VL) and method of measurement

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  4. Occurrence of HIV disease progression

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  5. Occurrence of each separate defining condition for HIV-disease progression

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  6. Occurrence of specific clinical events and death

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  7. 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)

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  8. Occurrence of potential immune-mediated diseases (pIMDs)

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  9. Occurrence of SAEs related to study participation

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

Secondary outcomes (8)

  1. Time between dose 1 and ART (re)-initiation or ART modification

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  2. Time between dose 1 and CD4 count measurement

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  3. Time between dose 1 and VL measurement

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  4. Time between dose 1 and occurrence of HIV disease progression

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  5. Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  6. Antibody concentrations to vaccine antigens

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  7. Cell-mediated immunity responses

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

  8. Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays)

    Measured: Once a year after Visit 1 (during a maximum of 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2010 (estimated)
  2. Study start22 Mar 2010
  3. Primary completion17 Mar 2014
  4. Study completion19 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01092611
Sponsor's protocol ID
114083
Other IDs
2009-018097-64, 2009
Status last verified
Mar 2018
First submitted
22 Mar 2010
Last updated
2 Mar 2018
Results posted
No

Publications

  • 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.

    PubMed 29606517

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Blood collection and GSK HIV vaccine 732462 in people with AIDS, run by GlaxoSmithKline at 41 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Germany, United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01092611, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.

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