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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status and phase: Completed; Phase 1

Conditions: HIV Infection

Treatments: Drug: Bryostatin 1 (10ug/m2); Other: Placebo; Drug: Bryostatin 1 (20ug/m2)

Study type: Interventional

Funder types: Other

Identifiers

NCT02269605

BRYOLAT

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

Patients receiving placebo (sodium chloride) at single dose

Treatment:

Other: Placebo

Group 2

Active Comparator group

Description:

Patients receiving Bryostatin 1 (10ug/m2) at single dose

Treatment:

Drug: Bryostatin 1 (10ug/m2)

Group 3

Active Comparator group

Description:

Patients receiving Bryostatin 1 (20ug/m2) at single dose

Treatment:

Drug: Bryostatin 1 (20ug/m2)