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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT02269605
• Date of registration: 16/10/2014
• Prospective Registration: No
• Primary sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Public title: Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment BRYOLAT
• Scientific title: Bryostatin-1 Effect on HIV-1 Latency and Reservoir HIV-1 Infected Patients Receiving Antiretroviral Treatment: Pilot, Controlled, Double Blinded, Dose Searching Trial
• Date of first enrolment: September 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02269605
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Spain

Contacts

• Name: Santiago Moreno, MD, PhD
• Affiliation: Hospital Universitario Ramón y Cajal

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Drug: Bryostatin 1 (20ug/m2)

Drug: Bryostatin 1 (10ug/m2)

Other: Placebo

Primary Outcome(s)

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(s)

Adverse Events [Time Frame: From baseline visit to day 28 after drug administration]

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]

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]

Secondary ID(s)

BRYOLAT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors