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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Group 1: Placebo (sodium chloride 0.8 %) at single dose
Group 2: Bryostatin 1 (10ug/m2) at single dose
Group 3: Bryostatin 1 (20ug/m2) at single dose
Infectious Diseases Service
Madrid, Non US/Canada, Spain
Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration
Time frame: Baseline visit and days 2 and 3 after the day of treatment
HIV-1 RNA level
Time frame: 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
Time frame: Baseline visit, day 1 and day 3
Episomal DNA with 2 LTRs level
Time frame: Baseline visit, day 1 and day 3
Adverse Events
Time frame: From baseline visit to day 28 after drug administration
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