AIDS 347: IL-6 Blockade in Treated HIV Infection

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over clinical trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving antiretroviral therapy with suppressed viral replication and CD4+ T cell count ≥350 and ≤1,000 cells/mm3)

Key facts

Study ID

NCT02049437

Run by

Case Western Reserve University

People needed

34

Starts

2014-08-01

Expected to finish

2017-09-11

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1.1 Men and women age 18-60 years.
• 1.2 Ability and willingness to communicate in English or Spanish
• 1.3 Ability and willingness of subject to provide informed consent.
• 1.4 Ability and willingness to provide adequate locator information.
• 1.5 HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test at any time before study entry and confirmed by a licensed Western blot, a second antibody test by a method other than rapid HIV or E/CIA; HIV-1 antigen; or plasma HIV-1 RNA viral load.
• 1.6 Receiving a stable antiretroviral regimen consisting of 3 or more drugs belonging to two or more classes, one of which must be a protease inhibitor, an integrase inhibitor, or a non-nucleoside reverse transcriptase inhibitor, without any changes due to virologic failure in the past 24 weeks, and with no plans to change antiretroviral regimen in the 40 weeks following enrollment. If the regimen includes a protease inhibitor, ritonavir or an approved boosting agent known to increase trough levels of the protease inhibitor by at least 50% must also be a part of the regimen.
• NOTE A: Changes to the antiretroviral regimen 8 weeks or more prior to enrollment are allowed if the plasma HIV RNA was <50 copies/mL at the time of the change, the reason for the change was not suspicion or documentation of virologic failure, and all other criteria for virologic control, as outlined in criterion 4.1.9 below, are met.
• NOTE B: For the purposes of this protocol, "a change due to virologic failure" is defined as any of the following events or combinations thereof happening in a patient who is receiving uninterrupted combination antiretroviral therapy including at least three agents belonging to at least two classes: a) plasma HIV RNA is >200 copies/mL on two or more consecutive occasions; b) the treating physician determines that any given plasma HIV RNA value is indicative or suggestive of virologic failure, and recommends that the patient's regimen be modified as a result; c) a genotypic or phenotypic antiretroviral resistance test identifies the presence of resistance to any component of a patient's regimen that was not present before, and a physician recommends that the patient's regimen be modified as a result.
• 1.7 For subjects who have a positive HBcAb only:
• An antiretroviral regimen containing one or more of the following medications: lamivudine, emtricitabine, or tenofovir.
• 1.8 Screening CD4+ T-cell count ≥350 cells/mm3 but ≤1,000 cells/mm3 performed in a laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
• 1.9 HIV-1 RNA <200 copies/mL at every time a plasma HIV RNA has been obtained, but no fewer than twice, in the 96 weeks prior to enrollment.
• NOTE: One plasma HIV RNA above 200 copies/mL but lower than 1,000 copies in the 96 weeks prior to enrollment is permissible if flanked by two measurements that are both below 200 copies. The HIV-1 RNA at screening must be <50 copies/mL.
• 1.10 The following laboratory values obtained within 60 days prior to entry:
• Hgb ≥10 g/dL
• Platelet count >100,000/mm3
• Absolute neutrophil count (ANC) ≥2,000 cells/mm3
• Aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase (SGOT)] <1.5x ULN
• Alanine aminotransferase (ALT) [serum glutamic pyruvic transaminase (SGPT)] <1.5x ULN
• For subjects who consent to undergo rectal tissue sampling only: International normalized ratio (INR) < 1.7
• Total bilirubin <3.0 mg/dL, EXCEPT for subjects receiving atazanavir
• For subjects receiving atazanavir: Direct bilirubin ≤1.0 mg/dL
• Calculated GFR ≥60 mL/min/1.73m2
• 1.11 Female subjects of reproductive potential must have a negative serum or urine pregnancy test at study entry and must affirm that they do not intend to become pregnant for the duration of the study.
• NOTE: For the purposes of this protocol, a female subject of reproductive potential is defined as one who has reached menarche, has not been post-menopausal for at least 24 consecutive months (i.e., has had menses within the preceding 24 months), and has not undergone surgical sterilization (e.g., hysterectomy, tubal ligation, or bilateral oophorectomy).

You may not qualify if…

• 2.1 History of one of the following opportunistic infections at any time in the past, as demonstrated by either a patient-reported or physician-documented diagnosis AND the initiation of specific treatment if applicable:
• Tuberculosis, pulmonary or extrapulmonary
• Non-tuberculous mycobacterial infection, disseminated or extrapulmonary
• Pneumocystis jirovecii pneumonia
• Coccidioidomycosis, disseminated or extrapulmonary
• Cryptococcosis, extrapulmonary
• Cryptosporidiosis or isosporiasis, chronic intestinal (greater than 1 month's duration)
• Cytomegalovirus disease (other than liver, spleen, or lymph nodes) and including retinitis with loss of vision
• Histoplasmosis, disseminated or extrapulmonary
• Kaposi's sarcoma
• Lymphoma, Burkitt's or immunoblastic, regardless of anatomical location
• Lymphoma, primary of brain
• Progressive multifocal leukoencephalopathy
• Toxoplasmosis of brain
• 2.2 Latent tuberculosis infection, defined as a positive or borderline FDA-approved interferon-gamma release assay (IGRA).
• 2.3 Pregnant or breastfeeding.
• 2.4 Active local or systemic infection (defined as requiring systemic antibiotics or other medical or surgical treatment) at the time of enrollment.
• 2.5 Use of systemic cancer chemotherapy or radiation therapy, immunosuppressive or immunomodulatory therapy (e.g., interferons, tumor necrosis factor antagonists, interleukins) or any investigational therapy within 90 days prior to study entry or continued indication for such medications. A list of prohibited study medications is provided in appendix 1 of the Manual of Operations (MOPS).
• NOTE A: Use of inhaled or nasal steroids, the equivalent of 10 mg of prednisone or less per day or a less than 2-week course of steroids are not exclusionary.
• NOTE B: A single course of 1% hydrocortisone cream or equivalent applied up to 3 times a day to <10 square inches area for <2 weeks is permitted. The investigators will determine if other forms of limited, short-term topical steroid use are expected to interfere significantly with the study objectives and are therefore exclusionary.
• 2.6 Receipt of a live attenuated vaccine within 30 days prior to study entry or expected need for such vaccines at any time during and for 30 days after the study.
• 2.7 Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation.
• 2.8 Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• 2.9 Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to study entry.
• 2.11 Known cirrhosis or severe liver disease (e.g., ascites, encephalopathy, history of variceal bleeding).

Where it is running

• Case Clinical Research Site — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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