Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The objective of the study is to compare two different doses of Peg-INF-α-2A (90 or 180 ug/wk) for their ability to maintain viral control when initiated 5 weeks before ART (antiretroviral therapy) interruption in HIV positive, ART-suppressed subjects (viral load \<50 copies/ml) as determined by observing the percentages of viral load measurements \<400 copies/ml between the two arms over a 24-week period, corresponding to the Pegasys monotherapy period (exclusive of dual ART/Pegasys 5-week period). Primary analysis will be an "intent to treat" analysis and will address the hypothesis that two different doses of Peg-INF-α-2A (90 and 180 ug/week) will be similarly effective at inhibiting viral replication.

Key facts

Study ID

NCT00594880

Run by

The Wistar Institute

People needed

23

Starts

2008-01-01

Expected to finish

2011-05-01

Last updated by the study team

2015-02-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age ≥ 18 but <65 years
• Able and willing to provide informed consent.
• HIV-1 infection documented by any licensed enzyme-linked immunosorbent assay (ELISA) test kit and confirmed by Western Blot at any time prior to or at study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
• HIV RNA < 75 copies/ml on a regimen of a) 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and 1 non-nucleoside RTI (NNRTI) OR b) 2 NRTIs and Protease Inhibitor (PI) for at least 24 weeks OR c) 3 NRTIs
• HIV RNA < 75 copies/ml at screening
• > 6 months ≥ 400 CD4+ T cells/mm3 (CD4 nadir ≥ 200 cells)
• Female subjects with childbearing potential: negative pregnancy test (Beta human horionic gonadotropin (HCG)). Must agree to use appropriate contraceptive methods (barrier devices such as diaphragms or condoms + spermicidal or intrauterine device (IUD) or oral contraceptives) while on study.
• Karnofsky performance scale score of 80% or better
• Willing to adhere to the treatment and schedule approved by the study investigators in conjunction with the patient's primary provider.
• Willing to abstain from immunomodulatory drugs during the study period, with the exception of the study drug (Pegasys®).
• Patient Health Questionnaire (PHQ)-2 score < 2, OR PHQ-9 score< 10, OR PHQ-9 score 10-14 AND medical provider's favorable opinion. In either case, score for PHQ-9 question # 9 (suicidal ideation) must be 0.
• Thyroid stimulating hormone (TSH) within normal range, unless accompanied by thyroid profile consistent with normal thyroid function
• A negative cardiac stress test 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 Hight density lipoprotein (HDL)-associated cholesterol (<40 mg/dL), family history of premature Coronary heart disease (CHD) (<55 yrs males/<65 females)] or a Framingham score > 15% (men) or 10% (women))

You may not qualify if…

• Currently pregnant or breast feeding.
• CD4 cell count < 400 or recorded CD4 nadir < 200 cells/mm3
• History of immunomodulatory therapy for over 2 weeks during the 6 months prior to enrollment, including, but not limited to: IFN-Alpha or Beta (recombinant or pegylated), systemic corticosteroids; 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; polyribonucleoside.
• Significant co-existing medical conditions including: Anemia (Hgb <9.1 men, <8.9 women), Neutropenia (ANC < 1000), Thrombocytopenia (platelet count <50K), Liver disease (AST/ALT > 5x, Total Bilirubin > 1.5x upper limits of normal, or Total Bilirubin >3x upper limit of the norm (ULN) if receiving indinavir), Renal disease (creatinine > 2x upper normal limits), or other conditions, such as active drug/alcohol abuse or dependence which would interfere with study compliance.
• Any history of heart attacks, myocardial infarction or coronary arterial disease (MI/CAD). .
• Prior history of major depression or other severe psychiatric disorder/condition requiring treatment and/or hospitalization
• PHQ-9 score >14, OR PHQ-9 score > 10 - 14 and lack of medical provider's favorable opinion, or score for PHQ-9 answer # 9 (suicidal ideation) > 0.
• Evidence of chronic active Hepatitis B infection (Surface Antigen HBsAg) or Hepatitis C plymerase chain reaction (PCR) positivity at screening (cleared of HCV at entry >6 months).
• Past evidence of medical conditions associated with chronic liver disease including genetic hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures etc.
• History of neutropenia or other hematological abnormalities
• Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin.
• Ongoing treatment with Isoniazide, Pyrazinamide, Rifabutin, Rifampicin, Diadenosine Ganciclovir, Valganciclovir, Oxymetholone, Thalidomide or Theophylline.
• History of autoimmune processes including Crohn's disease, ulcerative colitis, severe psoriasis, rheumatoid arthritis, myositis, hepatitis etc.
• History of major organ transplantation with an existing functional graft.
• Active coronary artery disease within 24 weeks prior to study
• Hemoglobinopathies such as sickle cell anemia or Thalassemia major.
• Hypersensitivity to Pegasys®or any of its components.

Where it is running

• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Penn-Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• The Wistar Institute — Philadelphia, Pennsylvania, United States
• Jonathan Lax Immune Disorders Clinic — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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