Status:
COMPLETED
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
HIV Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- Patients understanding the trial purpose
- 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
- Previous antiretroviral treatment failure, as any viral load outbreak after having had undetectable HIV-1 load. Low grade, transitory outbreaks (\<200 RNA copies/ml) resolved without treatment modifications are excluded
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02269605
Start Date
September 1 2014
End Date
December 1 2015
Last Update
December 18 2015
Active Locations (1)
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1
Infectious Diseases Service
Madrid, Non US/Canada, Spain, 28034