Skip to main content
OpenTrials
Completed

NCT Number: NCT02269605

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Infectious Diseases Service

Madrid, Non US/Canada, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Other

Group 1: Placebo (sodium chloride 0.8 %) at single dose

Bryostatin 1 (10ug/m2)

Drug

Group 2: Bryostatin 1 (10ug/m2) at single dose

Bryostatin 1 (20ug/m2)

Drug

Group 3: Bryostatin 1 (20ug/m2) at single dose

Primary outcomes

  1. 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 outcomes

  1. 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

  2. CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level

    Time frame: Baseline visit, day 1 and day 3

  3. Episomal DNA with 2 LTRs level

    Time frame: Baseline visit, day 1 and day 3

  4. Adverse Events

    Time frame: From baseline visit to day 28 after drug administration

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

Bryostatin-1 Effect on HIV-1 Latency and Reservoir HIV-1 Infected Patients Receiving Antiretroviral Treatment: Pilot, Controlled, Double Blinded, Dose Searching Trial

Acronym: BRYOLAT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.