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Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT) (MACRT)

Primary Purpose

HIV Infections, Cytomegalovirus Retinitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MSL-109
Placebo
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 13 years or older at entry Diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC) definition Diagnosis of active CMV retinitis as determined by a SOCA-certified ophthalmologist at time of enrollment At least one lesion whose size is one-quarter or more optic disc area Currently receiving (for relapsed patients) or scheduled to receive (for newly diagnosed patients) drugs for primary treatment of CMV retinitis that are not contraindicated for use with MSL-109 Visual acuity, in at least one eye that meets other eligibility criteria, of 3 or more letters on ETDRS chart at 1 meter distance (Snellen equivalent 5/200). Patients with poorer visual acuity may be enrolled if the visual acuity impairment is possibly reversible (eg, due to optic disc edema) and vision is at least light perception in that eye Karnofsky score of 60 or more Willingness and ability, with the assistance of a caregiver if necessary, to comply with treatment and follow up procedures signed consent statement Exclusion criteria: Current treatment with intravenous immune globulin (IVIG), CMV immune globulin (CMVIG), alpha-interferon (alpha-IFN), gamma-interferon (gamma-IFN) or interleukin-2 (IL-2) Media opacity that precludes visualization of the fundus in all eyes meeting eligibility criteria Active medical problems, including drug or alcohol abuse, that are considered sufficient to hinder compliance with treatment or follow up procedures Retinal detachment, not scheduled for surgical repair, in all eyes meeting other eligibility criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MSL-109

    Placebo

    Arm Description

    The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.

    Placebo administered intravenous infusion every 2 weeks 60 mg.

    Outcomes

    Primary Outcome Measures

    Mortality Rate
    to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 1999
    Last Updated
    October 14, 2015
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000135
    Brief Title
    Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
    Acronym
    MACRT
    Official Title
    Monoclonal Antibody CMV Retinitis Trial (MACRT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1995 (undefined)
    Primary Completion Date
    August 1996 (Actual)
    Study Completion Date
    August 1996 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.
    Detailed Description
    CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. As of September 1996, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment (induction) to control the infection followed by long-term lower dose treatment (maintenance) to prevent relapse. Ganciclovir is available in both intravenous and oral formulations, foscarnet only in an intravenous formulation, and cidofovir is given by intermittent intravenous administration. A surgically implanted intraocular sustained-release ganciclovir device (Vitrasert) is also approved by the FDA for the treatment of CMV retinitis. Despite the use of continuous maintenance therapy, given enough time, all patients with CMV retinitis on systemically administered drugs relapse. Preliminary studies suggested that the anti-CMV monoclonal antibody, MSL-109, when administered in conjunction with ganciclovir, markedly prolonged the time to relapse. Therefore, a randomized controlled clinical trial evaluating MSL-109 as adjunct therapy was conducted. The MACRT was a randomized, placebo-controlled, multicenter clinical trial evaluating the efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis. Patients with CMV retinitis, both those newly diagnosed and those suffering a relapse with active retinitis, were eligible. Primary therapy (e.g., ganciclovir, foscarnet, etc.) was determined by the treating local physician. The patients enrolled in the trial were randomized to either MSL-109 or placebo, administered as a rapid intravenous infusion every 2 weeks. Outcomes included survival, retinitis progression, change in amount of retinal area involved by CMV, loss of visual function (acuity and field), and morbidity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Cytomegalovirus Retinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    209 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MSL-109
    Arm Type
    Experimental
    Arm Description
    The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo administered intravenous infusion every 2 weeks 60 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    MSL-109
    Other Intervention Name(s)
    Monoclonal antibodies
    Intervention Description
    60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
    Primary Outcome Measure Information:
    Title
    Mortality Rate
    Description
    to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .
    Time Frame
    All patients enrolled were followed for a 17 month period or until a common study closing date

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: 13 years or older at entry Diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC) definition Diagnosis of active CMV retinitis as determined by a SOCA-certified ophthalmologist at time of enrollment At least one lesion whose size is one-quarter or more optic disc area Currently receiving (for relapsed patients) or scheduled to receive (for newly diagnosed patients) drugs for primary treatment of CMV retinitis that are not contraindicated for use with MSL-109 Visual acuity, in at least one eye that meets other eligibility criteria, of 3 or more letters on ETDRS chart at 1 meter distance (Snellen equivalent 5/200). Patients with poorer visual acuity may be enrolled if the visual acuity impairment is possibly reversible (eg, due to optic disc edema) and vision is at least light perception in that eye Karnofsky score of 60 or more Willingness and ability, with the assistance of a caregiver if necessary, to comply with treatment and follow up procedures signed consent statement Exclusion criteria: Current treatment with intravenous immune globulin (IVIG), CMV immune globulin (CMVIG), alpha-interferon (alpha-IFN), gamma-interferon (gamma-IFN) or interleukin-2 (IL-2) Media opacity that precludes visualization of the fundus in all eyes meeting eligibility criteria Active medical problems, including drug or alcohol abuse, that are considered sufficient to hinder compliance with treatment or follow up procedures Retinal detachment, not scheduled for surgical repair, in all eyes meeting other eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9400786
    Citation
    MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: the Monoclonal Antibody Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group. AIDS Clinical Trials Group. Arch Ophthalmol. 1997 Dec;115(12):1528-36. Erratum In: Arch Ophthalmol 1998 Mar;116(3):296.
    Results Reference
    result
    PubMed Identifier
    11919489
    Citation
    Jabs DA, Gilpin AM, Min YI, Erice A, Kempen JH, Quinn TC; Studies of Ocular Complications of AIDS Research Group. HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial. AIDS. 2002 Apr 12;16(6):877-87. doi: 10.1097/00002030-200204120-00007.
    Results Reference
    result
    PubMed Identifier
    12232843
    Citation
    Davidson M, Min YI, Holbrook JT, Van Natta M, Quinn TC, Murphy RL, Welch W, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Influence of filgrastim (granulocyte colony-stimulating factor) on human immunodeficiency virus type 1 RNA in patients with cytomegalovirus retinitis. J Infect Dis. 2002 Oct 1;186(7):1013-8. doi: 10.1086/342956. Epub 2002 Aug 29.
    Results Reference
    result
    PubMed Identifier
    12559647
    Citation
    Gilpin AM, Holbrook JT, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial. Control Clin Trials. 2003 Feb;24(1):92-8. doi: 10.1016/s0197-2456(02)00268-4.
    Results Reference
    result
    PubMed Identifier
    31042791
    Citation
    Holland GN, Van Natta ML, Goldenberg DT, Ritts R Jr, Danis RP, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Relationship Between Opacity of Cytomegalovirus Retinitis Lesion Borders and Severity of Immunodeficiency Among People With AIDS. Invest Ophthalmol Vis Sci. 2019 May 1;60(6):1853-1862. doi: 10.1167/iovs.18-26517.
    Results Reference
    derived

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    Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)

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