Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
NCT ID: NCT02269605
Last Updated: 2015-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Patients receiving placebo (sodium chloride) at single dose
Placebo
Group 1: Placebo (sodium chloride 0.8 %) at single dose
Group 2
Patients receiving Bryostatin 1 (10ug/m2) at single dose
Bryostatin 1 (10ug/m2)
Group 2: Bryostatin 1 (10ug/m2) at single dose
Group 3
Patients receiving Bryostatin 1 (20ug/m2) at single dose
Bryostatin 1 (20ug/m2)
Group 3: Bryostatin 1 (20ug/m2) at single dose
Interventions
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Placebo
Group 1: Placebo (sodium chloride 0.8 %) at single dose
Bryostatin 1 (10ug/m2)
Group 2: Bryostatin 1 (10ug/m2) at single dose
Bryostatin 1 (20ug/m2)
Group 3: Bryostatin 1 (20ug/m2) at single dose
Eligibility Criteria
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Inclusion Criteria
* Patients between 18 and 50 years of age
* Patients with chronic HIV-1 infection
* Patients receiving antiretroviral treatment with at least 3 active drugs for at least 2 years
* Undetectable viral load measured by ultra sensitive methods
* CD4+ levels higher than 350 cells/mm3
* Patients committed to use contraceptive methods during the trial and up to 3 months after.
Exclusion Criteria
* Patients planned to interrupt antiretroviral treatment during the trial
* Patients receiving immunosuppressant or immunostimulant drugs, including valproic acid.
* Pregnant women
* Bryostatin-1 hypersensitivity
* Being enrolled in another clinical trial or having participated in another clinical trial in the previous 3 months.
18 Years
50 Years
ALL
No
Sponsors
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Principal Investigators
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Santiago Moreno, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramón y Cajal
Locations
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Infectious Diseases Service
Madrid, Non US/Canada, Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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BRYOLAT
Identifier Type: -
Identifier Source: org_study_id