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| ID | Type | Description | Link |
|---|---|---|---|
| CTA file 9427-C1574-32C |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Ontario HIV Treatment Network | NETWORK |
| CIHR Canadian HIV Trials Network | NETWORK |
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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remune and ALVAC | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group | Up to week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group | Up to week 48 | |
| Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml | Up to week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan B Angel, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital, General Campus | Ottawa | Ontario | K1H 8L6 | Canada | ||
| CHUM Hotel-Dieu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21330911 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ALVAC With Remune | Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20. |
| FG001 | ALVAC With Remune Placebo | Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20. |
| FG002 | Both Placebos | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALVAC With Remune | Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20. |
| BG001 | ALVAC With Remune Placebo | Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group | Posted | Median | Inter-Quartile Range | days | Up to week 48 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALVAC With Remune | Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan B Angel | OHRI | 613-737-8442 | JANGEL@toh.ca |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C105086 | remune |
| C078788 | ALVAC vaccine |
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| 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. |
| Up to week 48 |
| 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. | Up to week 48 |
| HIV-specific Immune Function | at week 48 |
| Montreal |
| Quebec |
| H2W 1T8 |
| Canada |
| Montreal Chest Institute | Montreal | Quebec | H2X 2P4 | Canada |
| BG002 | Both Placebos | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Duration on ART | Median | Inter-Quartile Range | years |
|
| Baseline CD4 cell count | Median | Inter-Quartile Range | cells/ul |
|
| Baseline CD4% | Median | Inter-Quartile Range | percent |
|
| CD4 nadir | Median | Inter-Quartile Range | cells/ul |
|
| Pre-HAART HIV-RNA | Median | Inter-Quartile Range | log 10 (copies/ml) |
|
| Presence of 'protective' HLA allele | Protective HLA alleles include B27, B57, B58 | Number | participants |
|
|
|
| Secondary | Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group | Posted | Median | Inter-Quartile Range | days | Up to week 48 |
|
|
|
| Secondary | Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml | Only participants who reached 10,000 copies/ml are included in the analysis. | Posted | Median | Inter-Quartile Range | days | Up to week 48 |
|
|
|
| Secondary | 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. | Only participants whose viral loads reached a steady state are included in the analysis. | Posted | Median | Inter-Quartile Range | log10 copies/ml | Up to week 48 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | log10 copies/ml | Up to week 48 |
|
|
|
| Secondary | HIV-specific Immune Function | Data not collected for this assessment. | Posted | at week 48 |
|
|
| 0 |
| 19 |
| 12 |
| 19 |
| EG001 | ALVAC With Remune Placebo | Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20. | 0 | 18 | 10 | 18 |
| EG002 | Both Placebos | 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. | 0 | 15 | 4 | 15 |
| Subjective fever | General disorders |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |