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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| ViiV Healthcare | INDUSTRY |
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It is becoming clear that a combination of interventions will be desirable to achieve HIV cure. Therefore the investigators propose a pilot proof of concept study, using combination of a number of different interventions for eradicating residual plasma viremia and decreasing HIV reservoirs. The investigators hypothesize that, (i) antiretroviral intensification using Maraviroc, and/or dolutegravir with (ii) Dendritic Cell vaccination using autologous HIV, and (iii) purging intervention using the Class III HDACs, Sirtuin-1, and (iv) decreasing the ratio of long-lived central memory (TCM)/transitional memory (TTM) CD4+ T-cells using Auranofin will provide a synergistic impact leading to a sterilizing cure of HIV infection. Results of this study may provide insightful evidence for planning the next steps using the more efficacious combination of intervention strategies towards HIV sterilizing cure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiretroviral Treated (ART) Group | No Intervention | Five patients will receive no further intervention this group (control group) | |
| ART Intensification Group | Experimental | Five patients will receive antiretroviral intensification with maraviroc and dolutegravir for 48 weeks |
|
| ART Intensification + Nicotinamide Group | Experimental | Five patients will receive antiretroviral intensification with maraviroc and dolutegravir and the Sirtuin Histone deacetylase inhibitor nicotinamide for 48 weeks. |
|
| ART Intensification + Auranofin Group | Experimental | Five patients will receive antiretroviral intensification with maraviroc and dolutegravir for 48 weeks and the gold salt auranofin for 24 weeks. |
|
| ART Intensification + DC vaccine Group | Experimental | Five patients will receive antiretroviral intensification with dolutegravir and for 48 weeks, and dendritic cell vaccine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | antiretroviral intensification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasensitive RNA Viral load, | from baseline and every 4 weeks up to 48 weeks. | |
| Cell-associated HIV RNA | from baseline and every 4 weeks up to 48 weeks. | |
| Episomal DNA | from baseline and every 4 weeks up to 48 weeks | |
| specific HIV antibodies | from baseline and every 4 weeks up to 48 weeks | |
| CD38 and HLA-DR on CD4 and CD8+ cells | from baseline and every 4 weeks up to 48 weeks | |
| PBMC for env sequence evolution | from baseline and every 4 weeks up to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
A subject will NOT be eligible for study participation if he/she meets ANY of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCDI | São Paulo | São Paulo | 04040002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35022035 | Derived | de Almeida Baptista MV, da Silva LT, Samer S, Oshiro TM, Shytaj IL, Giron LB, Pena NM, Cruz N, Gosuen GC, Ferreira PRA, Cunha-Neto E, Galinskas J, Dias D, Sucupira MCA, de Almeida-Neto C, Salomao R, da Silva Duarte AJ, Janini LM, Hunter JR, Savarino A, Juliano MA, Diaz RS. Immunogenicity of personalized dendritic-cell therapy in HIV-1 infected individuals under suppressive antiretroviral treatment: interim analysis from a phase II clinical trial. AIDS Res Ther. 2022 Jan 12;19(1):2. doi: 10.1186/s12981-021-00426-z. | |
| 31394172 |
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|
| Multi Interventional Group | Experimental | Five patients will receive antiretroviral intensification with dolutegravir and the Sirtuin Histone deacetylase inhibitor nicotinamide for 48 weeks, and gold salt for 24 weeks and dendritic cell vaccine. |
|
|
| Dolutegravir | Drug | antiretroviral intensification |
|
|
| Dendritic Cell Vaccine | Biological | Therapeutic vaccination |
|
|
| Auranofin | Drug | purging |
|
|
| Sirtuin Histone deacetylase inhibitor | Drug | latency disruption |
|
|
| Derived |
| Diaz RS, Shytaj IL, Giron LB, Obermaier B, Della Libera E Jr, Galinskas J, Dias D, Hunter J, Janini M, Gosuen G, Ferreira PA, Sucupira MC, Maricato J, Fackler O, Lusic M, Savarino A; SPARC Working Group. Potential impact of the antirheumatic agent auranofin on proviral HIV-1 DNA in individuals under intensified antiretroviral therapy: Results from a randomised clinical trial. Int J Antimicrob Agents. 2019 Nov;54(5):592-600. doi: 10.1016/j.ijantimicag.2019.08.001. Epub 2019 Aug 5. |
| ID | Term |
|---|---|
| D000088562 | Persistent Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| C562325 | dolutegravir |
| C000706173 | lentiviral minigene vaccine of COVID-19 coronavirus |
| D001310 | Auranofin |
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006051 | Aurothioglucose |
| D050607 | Organogold Compounds |
| D009942 | Organometallic Compounds |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
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