NCT02269605: BRYOLAT

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

Completed Phase 1 Last updated 17 December 2015

What this trial tests

Phase 1 trial testing Placebo in HIV Infection in 12 participants. Completed in 1 December 2015.

Timeline

1 September 2014

Primary endpoint
1 January 2015

1 December 2015

Quick facts

Lead sponsor	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	12
Start date	1 September 2014
Primary completion	1 January 2015
Estimated completion	1 December 2015
Sites	1 location across Spain

Drugs / interventions tested

• Placebo
• Bryostatin 1 (10ug/m2) — full drug profile →
• Bryostatin 1 (20ug/m2) — full drug profile →

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Who can join

Adults 18 to 50, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. HIV-1 Eradication: Early Trials (and Tribulations).
   Spivak AM, Planelles V. · · 2016 · cited 93× · PMID 26691297 · DOI 10.1016/j.molmed.2015.11.004
2. Ongoing Clinical Trials of Human Immunodeficiency Virus Latency-Reversing and Immunomodulatory Agents.
   Delagrèverie HM, Delaugerre C, Lewin SR, Deeks SG, et al · · 2016 · cited 68× · PMID 27757411 · DOI 10.1093/ofid/ofw189
3. HIV-1 functional cure: will the dream come true?
   Liu C, Ma X, Liu B, Chen C, et al · · 2015 · cited 41× · PMID 26588898 · DOI 10.1186/s12916-015-0517-y
4. NF-κB sub-pathways and HIV cure: A revisit.
   Wong LM, Jiang G. · · 2021 · cited 39× · PMID 33340992 · DOI 10.1016/j.ebiom.2020.103159
5. Nanotechnology approaches to eradicating HIV reservoirs.
   Cao S, Woodrow KA. · · 2019 · cited 37× · PMID 29879528 · DOI 10.1016/j.ejpb.2018.06.002
6. Impact of Myeloid Reservoirs in HIV Cure Trials.
   Mitchell BI, Laws EI, Ndhlovu LC. · · 2019 · cited 28× · PMID 30835045 · DOI 10.1007/s11904-019-00438-5
7. Knowledge From London and Berlin: Finding Threads to a Functional HIV Cure.
   Ding J, Liu Y, Lai Y. · · 2021 · cited 18× · PMID 34122453 · DOI 10.3389/fimmu.2021.688747
8. Impacts of HIV Cure Interventions on Viral Reservoirs in Tissues.
   Denton PW, Søgaard OS, Tolstrup M. · · 2019 · cited 16× · PMID 31497010 · DOI 10.3389/fmicb.2019.01956