Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-07

Study Completion Date

2016-05-02

Brief Summary

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We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm, open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects (please refer to power calculations in section 10.1 below) currently stably suppressed (\> 1y with VL \< 50 copies/ml) on ART and with CD4 count \> 450 cells/µl.

We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected, immune-reconstituted individuals.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interferon alpha

pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks

Group Type EXPERIMENTAL

Pegylated Interferon alpha 2b

Intervention Type DRUG

1µg/kg/week

Interventions

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Pegylated Interferon alpha 2b

1µg/kg/week

Intervention Type DRUG

Other Intervention Names

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Pegintron

Eligibility Criteria

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Inclusion Criteria

* 18-65 years of age
* Body weight between 125 and 299 lbs
* Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral load
* 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
* HIV viral load of \<50 copies/ml at screening.
* CD4 \>450 cells/µL at screening.
* A negative ECG if \>45yrs men/\>55yrs women years of age or if below these years of age but with two added risk factors for coronary artery disease \[smoking, hypertension (BP \>140/90 or on antihypertensive medications), low HDL (\<40 mg/dL), family history of premature CHD (\<55 yrs males/\<65 females)\] or a Framingham score \> 15% (men) or 10% (women))

Exclusion Criteria

* 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 Isoniazide, pyrazinamide, Rifabutin, Rifampicin, Diadenosine Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
* 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-alpha or gamma (recombinant or pegylated), systemic corticosteroids (nasal or pulmonary steroids will be allowed; 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; polyribonucleotide.
* History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-alpha2a, IFN-α2b, IFN-beta)
* History of severe depression, 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.
* Prior diagnosis of multiple sclerosis or other neurodegenerative disorders
* Significant co-existing lab abnormalities including:

1. Anemia (Hgb \<9.1 mg/dl men, \<8.9 mg/dl women)
2. WBC \<2000 cells/µl
3. Absolute neutrophil count (ANC) \<1200 cells/ µl
4. Platelet count \<60,000 cells/ µl
5. Liver disease (AST/ALT \> 2.5x, Total Bilirubin \> 1.5x upper limits of norm (ULN), or Total Bilirubin \>3x ULN if receiving indinavir OR Atazanavir)
6. Renal disease (creatinine \> 2x upper normal limits 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 6 months prior to initiation of IFN
* Pregnancy, actively attempting to become pregnant, or breastfeeding
* Body weight under 125 lbs or over 300 lbs
* Other conditions, such as active drug/alcohol abuse or dependence which would interfere with study compliance

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No