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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Bryostatin 1 (10ug/m2)
Bryostatin 1 (20ug/m2)
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV reservoir, Bryostatin

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Infectious Diseases Service

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Patients receiving placebo (sodium chloride) at single dose

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

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

Outcomes

Primary Outcome Measures

Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration

Secondary Outcome Measures

HIV-1 RNA level
CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level
Episomal DNA with 2 LTRs level
Adverse Events

Full Information

First Posted
October 16, 2014
Last Updated
December 17, 2015
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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1. Study Identification

Unique Protocol Identification Number
NCT02269605
Brief Title
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
Acronym
BRYOLAT
Official Title
Bryostatin-1 Effect on HIV-1 Latency and Reservoir HIV-1 Infected Patients Receiving Antiretroviral Treatment: Pilot, Controlled, Double Blinded, Dose Searching Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV reservoir, Bryostatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo (sodium chloride) at single dose
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Patients receiving Bryostatin 1 (10ug/m2) at single dose
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Patients receiving Bryostatin 1 (20ug/m2) at single dose
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Group 1: Placebo (sodium chloride 0.8 %) at single dose
Intervention Type
Drug
Intervention Name(s)
Bryostatin 1 (10ug/m2)
Intervention Description
Group 2: Bryostatin 1 (10ug/m2) at single dose
Intervention Type
Drug
Intervention Name(s)
Bryostatin 1 (20ug/m2)
Intervention Description
Group 3: Bryostatin 1 (20ug/m2) at single dose
Primary Outcome Measure Information:
Title
Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration
Time Frame
Baseline visit and days 2 and 3 after the day of treatment
Secondary Outcome Measure Information:
Title
HIV-1 RNA level
Time Frame
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
Title
CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level
Time Frame
Baseline visit, day 1 and day 3
Title
Episomal DNA with 2 LTRs level
Time Frame
Baseline visit, day 1 and day 3
Title
Adverse Events
Time Frame
From baseline visit to day 28 after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Moreno, MD, PhD
Organizational Affiliation
Hospital Universitario Ramón y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Diseases Service
City
Madrid
State/Province
Non US/Canada
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12525599
Citation
Persaud D, Zhou Y, Siliciano JM, Siliciano RF. Latency in human immunodeficiency virus type 1 infection: no easy answers. J Virol. 2003 Feb;77(3):1659-65. doi: 10.1128/jvi.77.3.1659-1665.2003. No abstract available.
Results Reference
background
PubMed Identifier
12095377
Citation
Blankson JN, Gallant JE, Quinn TC, Bartlett JG, Siliciano RF. Loss of HIV-1-specific immunity during treatment interruption in 2 chronically infected patients. JAMA. 2002 Jul 10;288(2):162-4. doi: 10.1001/jama.288.2.162-a. No abstract available.
Results Reference
background
PubMed Identifier
19265012
Citation
Richman DD, Margolis DM, Delaney M, Greene WC, Hazuda D, Pomerantz RJ. The challenge of finding a cure for HIV infection. Science. 2009 Mar 6;323(5919):1304-7. doi: 10.1126/science.1165706.
Results Reference
background
PubMed Identifier
26891037
Citation
Gutierrez C, Serrano-Villar S, Madrid-Elena N, Perez-Elias MJ, Martin ME, Barbas C, Ruiperez J, Munoz E, Munoz-Fernandez MA, Castor T, Moreno S. Bryostatin-1 for latent virus reactivation in HIV-infected patients on antiretroviral therapy. AIDS. 2016 Jun 1;30(9):1385-92. doi: 10.1097/QAD.0000000000001064.
Results Reference
derived

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

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