HIV Infection
Conditions
Keywords
HIV reservoir, Bryostatin
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 receiving antiretroviral treatment.
Interventions
DRUGBryostatin 1 (10ug/m2)
Group 2: Bryostatin 1 (10ug/m2) at single dose
DRUGBryostatin 1 (20ug/m2)
Group 3: Bryostatin 1 (20ug/m2) at single dose
OTHERPlacebo
Group 1: Placebo (sodium chloride 0.8 %) at single dose
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration | Baseline visit and days 2 and 3 after the day of treatment |
Secondary
| Measure | Time frame |
|---|---|
| HIV-1 RNA level | 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 | Baseline visit, day 1 and day 3 |
| Episomal DNA with 2 LTRs level | Baseline visit, day 1 and day 3 |
| Adverse Events | From baseline visit to day 28 after drug administration |
Countries
Spain
Outcome results
None listed