Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Objectif Recherche Vaccins SIDA | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Pfizer | INDUSTRY |
| Merck Sharp & Dohme LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to discover a new approach in which human immunodeficiency virus (HIV) can be eradicated from an infected individual by intensified antiretroviral treatment coupled with immunomodulation. The hypothesis is that eradication is possible only if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory agent that simultaneously attack the viral reservoirs.
The objective of this study is to measure the impact of immunomodulation plus treatment intensification on the HIV reservoir in HIV-infected patients who have viral suppression on combination antiretroviral therapy. Treatment regimens first will be intensified by the addition of raltegravir and maraviroc for 8 week followed by immunomodulation with the NIH HIV-rAd5 vaccine plus DNA prime-boost for 24 weeks. The primary endpoint is measurement of change in peripheral cellular HIV DNA. A decrease of 0.5 log is considered significant. A secondary endpoints include change in HIV DNA in the rectal mucosa, immunologic changes in the peripheral blood and safety.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc + raltegravir intensification | Active Comparator | ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) |
|
| Maraviroc + raltegravir intens. plus DNA + HIV-rAd5 vaccine | Experimental | ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA + HIV-rAd5 vaccine | Biological | 4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HIV DNA in PBMCs at Week 56 | 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HIV DNA in Rectal Tissue at Week 56 | Week 56 | |
| Change From Baseline in CD4+ T Cell Count at Week 56 | Week 56 | |
| HIV Specific T-cell Response to Env |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Murphy, MD | Northwestern University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94110 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26424549 | Derived | Achenbach CJ, Assoumou L, Deeks SG, Wilkin TJ, Berzins B, Casazza JP, Lambert-Niclot S, Koup RA, Costagliola D, Calvez V, Katlama C, Autran B, Murphy RL; EraMune 02 study team. Effect of therapeutic intensification followed by HIV DNA prime and rAd5 boost vaccination on HIV-specific immunity and HIV reservoir (EraMune 02): a multicentre randomised clinical trial. Lancet HIV. 2015 Mar;2(3):e82-91. doi: 10.1016/S2352-3018(15)00026-0. Epub 2015 Feb 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ART Intensification: Maraviroc + Raltegravir | ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks |
| FG001 | Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine | ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ART Intensification: Maraviroc +Raltegravir | ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) |
| BG001 | Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine |
| 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 | Change From Baseline in HIV DNA in PBMCs at Week 56 | Posted | Median | Inter-Quartile Range | log^10 copies per 10^6 PBMCs | 56 weeks |
|
56 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maraviroc + Raltegravir Intensification | ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| creatine kinase | Musculoskeletal and connective tissue disorders | Systematic Assessment | Grade 4 creatine kinase |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baiba Berzins, MPH | Northwestern University | 312-695-5012 | baiba@northwestern.edu |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D004247 | DNA |
| D000068898 | Raltegravir Potassium |
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
Not provided
Not provided
| INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
| ART intensification (raltegravir) | Drug | raltegravir 400 mg PO BID for 56 weeks |
|
|
| ART intensification (maraviroc) | Drug | maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks |
|
|
HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting) |
| 36 weeks |
| Serious Adverse Events Attributed to Study Treatments | Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine) | 56 weeks |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Cornell University | New York | New York | 10011 | United States |
ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| CD4 cell count | Median | Inter-Quartile Range | cells per mm^3 |
|
| Time on antiretroviral treatment (ART) | Median | Inter-Quartile Range | years |
|
| Adenovirus 5 antibody | Serum Ad5 90% neutralization antibody titer | Median | Inter-Quartile Range | titer |
|
| HIV DNA | Median | Inter-Quartile Range | copies per 10^6 PBMC |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in HIV DNA in Rectal Tissue at Week 56 | Posted | Median | Inter-Quartile Range | log^10 copies per 10^6 cells | Week 56 |
|
|
|
| Secondary | Change From Baseline in CD4+ T Cell Count at Week 56 | Posted | Median | Inter-Quartile Range | cells per mm^3 | Week 56 |
|
|
|
| Secondary | HIV Specific T-cell Response to Env | HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting) | Posted | Median | Standard Deviation | response per 10^6 PBMCs | 36 weeks |
|
|
|
| Secondary | Serious Adverse Events Attributed to Study Treatments | Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine) | Posted | Number | serious adverse events | 56 weeks |
|
|
|
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine | ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32) | 3 | 14 | 0 | 14 |
|
| acute coronary syndrome | Cardiac disorders | Systematic Assessment | Grade 3 left arm, neck and chest pain |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment | Grade 4 acute renal failure, Grade 4 creatinine |
|
| deep vein thrombosis | Vascular disorders | Non-systematic Assessment | Grade 3 deep vein thrombosis |
|
Not provided
Not provided
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |