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Histone Deacetylase Inhibitor

Pegylated Interferon-alpha2a + Panobinostat for HIV/AIDS (ACTIVATE Trial)

Phase 1 & 2
Waitlist Available
Led By Mathias Lichterfeld, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of clinical coronary heart disease
No clinically significant eye disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all adverse events measured from day 1 until day 28 after administration of the first dose of panobinostat and/or interferon-alpha2a was recorded.
Awards & highlights

ACTIVATE Trial Summary

This trial will study whether a combination of two drugs can reduce the amount of HIV-infected cells in people who are already taking antiretroviral drugs.

Eligible Conditions
  • HIV/AIDS

ACTIVATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ACTIVATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all adverse events measured from day 1 until day 28 after administration of the first dose of panobinostat and/or interferon-alpha2a was recorded.
This trial's timeline: 3 weeks for screening, Varies for treatment, and all adverse events measured from day 1 until day 28 after administration of the first dose of panobinostat and/or interferon-alpha2a was recorded. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CD4 T Cell-Associated Proviral HIV-1 DNA From Baseline
Occurrence of Grade ≥ 1 Adverse Events (AEs)
Secondary outcome measures
Change From Baseline in Frequency of Activated NKp30+ NK Cells.
Change From Baseline in Histone H3 Acetylation in CD4 T Cells
Change From Baseline in Levels of CD4 T Cell-associated HIV-1 RNA

Side effects data

From 2012 Phase 3 trial • 41 Patients • NCT01034163
88%
Diarrhoea
58%
Nausea
46%
Vomiting
35%
Fatigue
27%
Neutropenia
27%
Thrombocytopenia
27%
Oropharyngeal pain
23%
Headache
19%
Upper respiratory tract infection
19%
Nasopharyngitis
15%
Sinusitis
15%
Influenza like illness
15%
Pyrexia
15%
Decreased appetite
12%
Leukopenia
12%
Muscle spasms
12%
Depression
12%
Arthralgia
12%
Cough
12%
Dysgeusia
12%
Gastrooesophageal reflux disease
12%
Asthenia
8%
Urinary tract infection
8%
Mucosal dryness
8%
Herpes virus infection
8%
Back pain
8%
Polyneuropathy
8%
Paranasal sinus hypersecretion
8%
Abdominal pain upper
8%
Constipation
8%
Platelet count decreased
4%
Sinusitis bacterial
4%
Cellulitis
4%
Gastroenteritis salmonella
4%
Insomnia
4%
Non-cardiac chest pain
4%
Hypophosphataemia
4%
Pruritus
4%
Abdominal pain
4%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Panobinostat (PAN)

ACTIVATE Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment1 Intervention
Participants in Arm C will receive one subcutaneous injection of pegylated interferon-alpha2a on day 0.The dose of pegylated IFN-alpha2a will be 180 mcg.
Group II: Arm BExperimental Treatment2 Interventions
Participants in Arm B will receive one subcutaneous injection of pegylated interferon-alpha2a on day 0. The dose of pegylated IFN-alpha2a will be 180 mcg. Simultaneously with interferon-alpha2a, a 15 mg tablet of panobinostat will be administered on day 0. Participants will also receive panobinostat as an oral tablet on days 2 and 4 of the treatment week.
Group III: Arm AExperimental Treatment1 Intervention
Participants in Arm A will receive panobinostat as an oral tablet on days 0, 2, and 4 of the treatment week. The dose of panobinostat will be a 15 mg tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegylated Interferon-alpha2a
2016
Completed Phase 4
~70
Panobinostat
2011
Completed Phase 3
~1560

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,818 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,663 Total Patients Enrolled
NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,709,774 Total Patients Enrolled

Media Library

Panobinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02471430 — Phase 1 & 2
HIV/AIDS Research Study Groups: Arm B, Arm C, Arm A
HIV/AIDS Clinical Trial 2023: Panobinostat Highlights & Side Effects. Trial Name: NCT02471430 — Phase 1 & 2
Panobinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02471430 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents for the usage of Panobinostat in clinical research?

"Currently, 25 trials are in progress exploring Panobinostat. Of these studies, two have reached Phase 3 status. The majority of research sites dedicated to investigating this medication are located in Barcelona and New york City; however, 411 clinical trial centres across the globe are participating."

Answered by AI

Does this research project currently have openings for participants?

"This clinical trial has ended its recruitment phase. It was initially published on May 1st 2016 and last edited on July 6th 2022. For those seeking other trials, there are currently 634 studies recruiting HIV-infected patients and 25 Panobinostat trials searching for participants."

Answered by AI

To what end is Panobinostat normally prescribed?

"Panobinostat can potentially treat multiple chronic and compensated liver diseases, including hepatitis b and C."

Answered by AI

How many participants are partaking in this medical research?

"This research endeavour is no longer seeking participants, having been initially posted on May 1st 2016 and last updated on July 6th 2022. If you are in search of other studies, there are currently 634 clinical trials actively recruiting individuals with HIV infections and 25 separate initiatives utilizing Panobinostat that require volunteers."

Answered by AI

Does your study accept elderly participants?

"This experiment necessitates that qualified participants fall between the ages of 18-65. Separate trials are available for those younger than 18, and those older than 65; 153 in total for minors and 485 for seniors."

Answered by AI

Is it possible for me to participate in this research endeavor?

"To be admitted to this trial, applicants must possess HIV infections and meet the age range of 18-65. In total, 34 participants are being accepted for the study."

Answered by AI
Recent research and studies
~2 spots leftby Mar 2025