Overview
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
Status:
Completed
Completed
Trial end date:
2015-12-01
2015-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trialĀ“s goal is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1 infected patients receiving antiretroviral treatment.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalTreatments:
Bryostatin 1
Criteria
Inclusion Criteria:- 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 Criteria:
- 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.