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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT02269605
First received: October 16, 2014
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
HIV Infection Other: Placebo Drug: Bryostatin 1 (10ug/m2) Drug: Bryostatin 1 (20ug/m2) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level [ Time Frame: Baseline visit, day 1 and day 3 ]
  • Episomal DNA with 2 LTRs level [ Time Frame: Baseline visit, day 1 and day 3 ]
  • Adverse Events [ Time Frame: From baseline visit to day 28 after drug administration ]

Enrollment: 12
Study Start Date: September 2014
Study Completion Date: December 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1
Patients receiving placebo (sodium chloride) at single dose
Other: Placebo
Group 1: Placebo (sodium chloride 0.8 %) at single dose
Active Comparator: Group 2
Patients receiving Bryostatin 1 (10ug/m2) at single dose
Drug: Bryostatin 1 (10ug/m2)
Group 2: Bryostatin 1 (10ug/m2) at single dose
Active Comparator: Group 3
Patients receiving Bryostatin 1 (20ug/m2) at single dose
Drug: Bryostatin 1 (20ug/m2)
Group 3: Bryostatin 1 (20ug/m2) at single dose

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02269605

Locations
Spain
Infectious Diseases Service
Madrid, Non US/Canada, Spain, 28034
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Investigators
Principal Investigator: Santiago Moreno, MD, PhD Hospital Universitario Ramón y Cajal
  More Information

Publications:
Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02269605     History of Changes
Other Study ID Numbers: BRYOLAT
Study First Received: October 16, 2014
Last Updated: December 17, 2015

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
HIV reservoir
Bryostatin

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Bryostatin 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017