Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy (ACTIVATE)
HIV Infection
About this trial
This is an interventional treatment trial for HIV Infection
Eligibility Criteria
Inclusion Criteria:
- Ability and willingness to provide informed consent
- HIV-1 infection prior to entry
- Receiving suppressive ART therapy for a minimum of 24 consecutive months prior to screening with no interruption of therapy (same ART regimen for at least 12 weeks prior to screening)
- Documented suppressed HIV-1 RNA (plasma HIV-1 RNA values <50 copies/ml)
- CD4 T cell count ≥ 400 cells/mm3
- Negative Hepatitis B surface antigen (HBsAg) or Negative HBV DNA PCR
- Negative anti-Hepatitis C virus antibodies (anti-HCV) or negative HCV PCR if anti-HCV antibodies are positive
- Negative TB Test (if positive, completed a recommended treatment course for latent TB)
- Vaccinated for pneumococcal disease within last 5 years
- No clinically significant eye disease
- No evidence of clinical coronary heart disease
- Not pregnant, planning to become pregnant, or breastfeeding
- Willingness to continue to use contraceptives for 90 days after completing treatment
- If male, willingness to use a condom during intercourse while taking panobinostat and total of 80 hours after stopping treatment
- Not pregnant, planning to become pregnant, or breastfeeding
- No evidence of coronary heart disease
Exclusion Criteria:
- HIV-1 RNA > 50 copies/mL within 24 months of screening
- Severe psychiatric disease, chronic liver disease, past or current evidence of immunologically mediated disease
- Severe retinopathy due to diabetes, hypertension, cytomegalovirus or macular degeneration
- Evidence of coronary heart disease
- History of active thyroid disease requiring medication
- Breastfeeding
- Presence of a bacterial, fungal, viral or protozoal infection requiring systemic anti-infective therapy
- Uncontrolled seizure disorders
- History or other evidence of severe illness or other conditions
- History of malignancy of any organ system within the past 5 years
- Female participants who are pregnant or nursing
- History of solid organ transplantation with an existing functional graft
- Use of any immunomodulatory agents within 30 days prior to study enrollment or planned use during the trial
- Active drug or alcohol use or dependence
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in case of participation in the study
- Use of HIV protease inhibitor or other strong or moderately strong CYP3A4 inhibitors
- History of anaphylaxis, allergy or serious adverse reactions to Interferon-alpha2a/Interferon-alpha2b or panobinostat
- Has taken: interleukins, systemic interferons or systemic chemotherapy
Sites / Locations
- Massachusetts General Hospital CRS (MGH CRS)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A
Arm B
Arm C
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.
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.
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.