Phase 2
N=20
Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT01935089 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24 — 113; 98 HIV DNA copies per CD4+ T cell — p=0.0797
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pegylated Interferon alpha 2b (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Wistar Institute
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24 |
113; 98 | 0.0797 |
Summary
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 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.
Eligibility Criteria
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 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 ( 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:
- Anemia (Hgb 2.5x, Total Bilirubin > 1.5x upper limits of norm (ULN), or Total Bilirubin >3x ULN if receiving indinavir OR Atazanavir)
- Renal disease (creatinine > 2x upper normal limits or creatinine clearance 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
Data sourced from ClinicalTrials.gov (NCT01935089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.