HIV InfectionPhase 1BRYOLATNCT02269605
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
A Phase 1 study testing Bryostatin 1 (10ug/m2) and Bryostatin 1 (20ug/m2) in people with HIV Infection, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Bryostatin 1 (10ug/m2) and Bryostatin 1 (20ug/m2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- HIV Infection
- Being tested
- Placebo, Bryostatin 1 (10ug/m2), Bryostatin 1 (20ug/m2)
- Keywords
- HIV reservoir, Bryostatin
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Patients receiving placebo (sodium chloride) at single dose Receives: Other: Placebo |
| Group 2 | Active comparator | Patients receiving Bryostatin 1 (10ug/m2) at single dose Receives: Drug: Bryostatin 1 (10ug/m2) |
| Group 3 | Active comparator | Patients receiving Bryostatin 1 (20ug/m2) at single dose Receives: Drug: Bryostatin 1 (20ug/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration
Measured: Baseline visit and days 2 and 3 after the day of treatment
Secondary outcomes (4)
HIV-1 RNA level
Measured: 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
Measured: Baseline visit, day 1 and day 3
Episomal DNA with 2 LTRs level
Measured: Baseline visit, day 1 and day 3
Adverse Events
Measured: From baseline visit to day 28 after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santiago Moreno, MD, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269605
- Sponsor's protocol ID
- BRYOLAT
- Acronym
- BRYOLAT
- Status last verified
- Dec 2015
- First submitted
- 16 Oct 2014
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12525599Blankson 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.
PubMed 12095377Richman 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.
PubMed 19265012Gutierrez 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.
PubMed 26891037
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02269605
- Acronym / sponsor ID
- BRYOLAT / BRYOLAT
- Conditions
- HIV Infection
- Keywords
- HIV reservoir, Bryostatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Other: PlaceboPatients receiving placebo (sodium chloride) at single dose |
| Group 2 | Active comparator | Drug: Bryostatin 1 (10ug/m2)Patients receiving Bryostatin 1 (10ug/m2) at single dose |
| Group 3 | Active comparator | Drug: Bryostatin 1 (20ug/m2)Patients receiving Bryostatin 1 (20ug/m2) at single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboGroup 1: Placebo (sodium chloride 0.8 %) at single dose | Other | Group 1 |
| Bryostatin 1 (10ug/m2)Group 2: Bryostatin 1 (10ug/m2) at single dose | Drug | Group 2 |
| Bryostatin 1 (20ug/m2)Group 3: Bryostatin 1 (20ug/m2) at single dose | Drug | Group 3 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Background: PubMed 12525599Persaud 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.
- Background: PubMed 12095377Blankson 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.
- Background: PubMed 19265012Richman 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.
- Derived from this study: PubMed 26891037Gutierrez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Moreno, MD, PhD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bryostatin 1 (10ug/m2) and Bryostatin 1 (20ug/m2) in people with HIV Infection, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269605, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.