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Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1 infected patients receiving antiretroviral treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Patients receiving placebo (sodium chloride) at single dose |
|
| Group 2 | Active Comparator | Patients receiving Bryostatin 1 (10ug/m2) at single dose |
|
| Group 3 | Active Comparator | Patients receiving Bryostatin 1 (20ug/m2) at single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Group 1: Placebo (sodium chloride 0.8 %) at single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration | Baseline visit and days 2 and 3 after the day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA level | Baseline visit, day 0 (15, 30, 60 minutes after begining of drug administration and 1, 2, 4, 8, 12 hours after begining of drug administration) and days 1, 2 and 3 | |
| CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level | Baseline visit, day 1 and day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Moreno, MD, PhD | Hospital Universitario Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Service | Madrid | Non US/Canada | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12525599 | Background | Persaud D, Zhou Y, Siliciano JM, Siliciano RF. Latency in human immunodeficiency virus type 1 infection: no easy answers. J Virol. 2003 Feb;77(3):1659-65. doi: 10.1128/jvi.77.3.1659-1665.2003. No abstract available. | |
| 12095377 | Background | Blankson JN, Gallant JE, Quinn TC, Bartlett JG, Siliciano RF. Loss of HIV-1-specific immunity during treatment interruption in 2 chronically infected patients. JAMA. 2002 Jul 10;288(2):162-4. doi: 10.1001/jama.288.2.162-a. No abstract available. |
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| Bryostatin 1 (10ug/m2) |
| Drug |
Group 2: Bryostatin 1 (10ug/m2) at single dose |
|
| Bryostatin 1 (20ug/m2) | Drug | Group 3: Bryostatin 1 (20ug/m2) at single dose |
|
| Episomal DNA with 2 LTRs level | Baseline visit, day 1 and day 3 |
| Adverse Events | From baseline visit to day 28 after drug administration |
| 19265012 | Background | Richman DD, Margolis DM, Delaney M, Greene WC, Hazuda D, Pomerantz RJ. The challenge of finding a cure for HIV infection. Science. 2009 Mar 6;323(5919):1304-7. doi: 10.1126/science.1165706. |
| 26891037 | Derived | Gutierrez C, Serrano-Villar S, Madrid-Elena N, Perez-Elias MJ, Martin ME, Barbas C, Ruiperez J, Munoz E, Munoz-Fernandez MA, Castor T, Moreno S. Bryostatin-1 for latent virus reactivation in HIV-infected patients on antiretroviral therapy. AIDS. 2016 Jun 1;30(9):1385-92. doi: 10.1097/QAD.0000000000001064. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
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| ID | Term |
|---|---|
| C046785 | bryostatin 1 |
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