Status:
UNKNOWN
Reducing Proviral HIV DNA With Interferon-a
Lead Sponsor:
The Wistar Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
HIV/AIDS
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if treatment with pegylated interferon alpha 2b (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and tissues of individual...
Detailed Description
Our long-term goal is to evaluate the effect of pegylated interferon (peg-IFN) α as an anti-HIV reservoir immunotherapy that could potentiate eradication strategies against HIV. The present study is ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 18-65 years of age
- Body weight ≥ 125 and ≤ 300 lbs
- Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral load at screening.
- Currently receiving ART and on ART for ≥ 1 year
- VL \< 50 copies/ml for ≥ 1 year, with at least 2 measurements in the previous year. 1 viral "blip" with VL\< 400 copies/ml allowed if 1 or more measurements of \< 50 copies/ml are available no more than 3 months before and 3 months after the "blip" without change in ART
- HIV viral load of \<50 copies/ml at screening.
- CD4 \>450 cells/µL at screening.
- a negative electrocardiogram (EKG, see section 7.4) for: a) men \>45 years or women \> 55 years of age b) younger subjects of either sex with two risk factors for coronary artery disease \[smoking, hypertension (BP \>140/90 or on antihypertensive medications), low HDL (\<40 mg/dl), family history of premature CHD (\<55 yrs males/\<65 females, c) subjects with a Framingham score \> 15% (men) or 10% (women)
- Exclusion criteria Current or prior medications
- Confirmed clinical history of developing resistance to ART regimens that resulted in treatment changes
- Receiving didanosine as part of the participant's ART regimen at the time of screening
- Ongoing treatment with Isoniazid, Pyrazinamide, Rifabutin, Rifampicin, Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
- Ongoing treatment with anticoagulants
- Use of any investigational drug within 30 days prior to screening
- History or current use of immunomodulatory therapy for over 2 weeks during the 6 months prior to enrollment, including, but not limited to: IFN-α or γ (recombinant or pegylated), systemic corticosteroids (inhaled steroids allowed at the discretion of the Investigator); systemic cancer chemotherapy/irradiation; cyclosporin; tacrolimus (FK-506); OKT-3; any Interleukin, including IL-2; cyclophosphamide; methotrexate; IVIG (gamma globulin); G/M-CSF; hydroxyurea; thalidomide; pentoxifylline; thymopentin; thymosin; dithiocarbonate; polyribonucloside.
- History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-α2a, IFN-α2b, IFN-β)
- Current or prior clinical conditions
- History of severe depression, including history of suicidal ideation or attempt, or ongoing moderate depression determined by PHQ-9 at screening
- Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin (i.e.: subjects with a history of diabetes mellitus and HA1C of \> 9 in the last 3 months or at screening).
- Prior diagnosis of multiple sclerosis or other neurodegenerative disorders
- Significant co-existing lab abnormalities including: a) Anemia (Hgb \<9.1 mg/dl men, \<8.9 mg/dl women); b) Ongoing coagulopathy/clotting disorder; c) WBC \<2000 cells/µl; d) Absolute neutrophil count (ANC) \<1200 cells/ µl; e) Platelet count \<60,000 cells/ µl; f) Liver disease (AST/ALT \> 2.5x OR total bilirubin \> 1.5x upper limits of norm (ULN), (if not receiving atazanavir) or direct bilirubin \> 0.6 (if receiving atazanavir); g) Pancreatic disease (amylase : \> 1.5 ULN, lipase \> 1.5 ULN, triglycerides \> 750 mg/dl); h Renal disease (creatinine \> 2x ULN or creatinine clearance \<60mg/dl (by Crockoff-Gault)
- Chronic HCV infection (HCV viremia), or HBV Ag positive and/ or HBV viremia (Notice: subjects with prior HCV infection with a documented sustained virologic response with treatment finishing \>1 year prior to screening are eligible for enrollment).
- Liver cirrhosis or hepatic decompensation with Child Pugh score \> 6
- History of major organ transplantation with an existing functional graft.
- Evidence of OI or other active infectious diseases or active malignancies
- Active Autoimmune diseases, including autoimmune hepatitis
- History of retinopathy or clinically significant ophthalmologic disease on eye exam performed within 60 days prior to initiation of IFN
- Significant EKG abnormalities (see section 7.4)
- Other conditions
- Pregnancy or breastfeeding
- A planned pregnancy during study participation
- Lack of one of three strategies for birth control during study participation: a) Barrier contraceptives (male or female condoms with or without a spermicidal agent, diaphragm or cervical cap with spermicidal); b) Non-hormonal Intrauterine Devices (IUDs); c) Hormonal-based, including hormonal IUDs, in combination with barrier contraceptives.
- Body weight \< 125 lbs or \> 300 lbs
- Other conditions, such as active drug/alcohol abuse or dependence,that in the opinion of the Investigator would interfere with study compliance.
Exclusion
Key Trial Info
Start Date :
February 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02227277
Start Date
February 11 2015
End Date
July 24 2018
Last Update
April 5 2018
Active Locations (3)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Penn-Presbyterian Hospital
Philadelphia, Pennsylvania, United States, 19104
3
Jonathan Lax Center at Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107