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HIV InfectionsPhase 1/2NCT00212888

Combination Vaccination Before HIV Treatment Interruption

A Phase 1/2 study testing Remune and ALVAC in people with HIV Infections, run by Ottawa Hospital Research Institute at 3 sites in Canada.

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 study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Remune and ALVAC
How many people
52 participants
Where
3 sitesCanada
Study dates
Apr 2004to Nov 2010
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented HIV infection (by serology)
  • HIV RNA level below 50 copies/ml for at least two years
  • Receiving at least 2 antiretroviral agents including at least 1 protease inhibitor or 1 non-nucleoside reverse transcriptase inhibitor at time of screening
  • Have CD4 counts above 500 cells/ul
  • Have CD4/CD8 ratio above 0.5
  • Have never had a CD4 count below 250
Show all 9Show fewer
  • No previous AIDS-defining opportunistic infection
  • No previous cancer chemotherapy or other system immunosuppressive therapy (excluding brief courses [<= 1 month] of prednisone or its equivalent)
  • Able to provide informed consent

Who cannot join

  • Hepatitis B surface antigen positive
  • Hepatitis C antibody positive
  • AST, ALT, ALP, creatinine, urea above three times the normal upper limit
  • Blood abnormalities (hemoglobin lower than 100, white blood cell count [WBC] lower than 1500 or platelets lower than 100)
  • Allergies to components of Remune™ or ALVAC
  • Contraindications to vaccine components
  • Pregnancy or breastfeeding

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • CHUM Hotel-Dieu

    Montreal, Quebec, H2W 1T8

  • Montreal Chest Institute

    Montreal, Quebec, H2X 2P4

  • The Ottawa Hospital, General Campus

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: A Pilot Study to Determine the Impact of Therapeutic HIV Vaccination Followed by a Scheduled Interruption of Antiretroviral Therapy on HIV-Specific Immune Function and Virologic Rebound in Patients With Prolonged Viral Suppression

The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.

Read the detailed description

Volunteers will be randomly assigned to receive the vaccines or matching placebos before interrupting their antiretroviral therapy at week 24.

Dosage:

Remune(TM) 1 ml i.m.* at weeks 0, 12, and 20; ALVAC 1 ml i.m.* at weeks 8,12, 16, and 20.

  • i.m.: injected in a muscle
Conditions
HIV Infections
Being tested
Remune and ALVAC
Keywords
HIV, Vaccination
Medical subject headings
HIV Infections

What participants receive

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

  • Remune and ALVACBiological

    • Group 1) Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20);
    • Group 2) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20; or
    • Group 3) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.

What is being measured

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

  1. Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group

    Measured: Up to week 48

Secondary outcomes (5)

  1. Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group

    Measured: Up to week 48

  2. Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml

    Measured: Up to week 48

  3. Viral Set-point

    Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.

    Measured: Up to week 48

  4. Magnitude of Viral Rebound

    Magnitude of viral rebound is the amount of HIV viral load an infected person who was previously on ART and suppressed below clinical detection rebounds to following ART stoppage. This will typically be compared to the viral load before starting ART or Viral set-point discussed earlier.

    Measured: Up to week 48

  5. HIV-specific Immune Function

    Measured: at week 48

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionJul 2010
  4. Study completionNov 2010

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00212888
Sponsor's protocol ID
2000456-01H
Other IDs
CTA file 9427-C1574-32C
Status last verified
Mar 2019
First submitted
13 Sep 2005
Last updated
17 Jun 2019
Data monitoring committee
Yes

Publications

  • Angel JB, Routy JP, Tremblay C, Ayers D, Woods R, Singer J, Bernard N, Kovacs C, Smaill F, Gurunathan S, Sekaly RP. A randomized controlled trial of HIV therapeutic vaccination using ALVAC with or without Remune. AIDS. 2011 Mar 27;25(6):731-9. doi: 10.1097/QAD.0b013e328344cea5.

    PubMed 21330911

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Remune and ALVAC in people with HIV Infections, run by Ottawa Hospital Research Institute at 3 sites in Canada.

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 9 inclusion and 7 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group (time frame: Up to week 48). 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 NCT00212888, 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 17 Jun 2019.

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