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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000135
Recruitment Status : Completed
First Posted : September 24, 1999
Results First Posted : November 17, 2015
Last Update Posted : November 17, 2015
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.

Condition or disease Intervention/treatment Phase
HIV Infections Cytomegalovirus Retinitis Drug: MSL-109 Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Monoclonal Antibody CMV Retinitis Trial (MACRT)
Study Start Date : September 1995
Actual Primary Completion Date : August 1996
Actual Study Completion Date : August 1996

Arm Intervention/treatment
Experimental: MSL-109
The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
Drug: MSL-109
60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
Other Name: Monoclonal antibodies

Placebo Comparator: Placebo
Placebo administered intravenous infusion every 2 weeks 60 mg.
Other: Placebo
60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.

Primary Outcome Measures :
  1. Mortality Rate [ Time Frame: All patients enrolled were followed for a 17 month period or until a common study closing date ]
    to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johns Hopkins Bloomberg School of Public Health Identifier: NCT00000135     History of Changes
Other Study ID Numbers: NEI-34
First Posted: September 24, 1999    Key Record Dates
Results First Posted: November 17, 2015
Last Update Posted: November 17, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Cytomegalovirus Retinitis
Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Antineoplastic Agents, Immunological
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents