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

Phase 1

Completed

• Conditions: HIV Infection
• Interventions: Other: Placebo; Drug: Bryostatin 1 (10ug/m2); Drug: Bryostatin 1 (20ug/m2)

• Registration Number: NCT02269605
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-21
• Primary Completion: 2015-01
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	Patients receiving placebo (sodium chloride) at single dose
Group 2	Bryostatin 1 (10ug/m2)	Patients receiving Bryostatin 1 (10ug/m2) at single dose
Group 3	Bryostatin 1 (20ug/m2)	Patients receiving Bryostatin 1 (20ug/m2) at single dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Episomal DNA with 2 LTRs level	Baseline visit, day 1 and day 3
CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level	Baseline visit, day 1 and day 3
Adverse Events	From baseline visit to day 28 after drug administration

Trial Locations

Locations (1)

Infectious Diseases Service; 🇪🇸 Madrid, Non US/Canada, Spain