Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 receiving antiretroviral treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Treatments: 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.