NCT00000135

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Sep 1995

Shorter than P25 for phase_2 hiv-infections

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
16.2 years until next milestone

Results Posted

Study results publicly available

November 17, 2015

Completed
Last Updated

November 17, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

September 23, 1999

Results QC Date

June 12, 2015

Last Update Submit

October 14, 2015

Conditions

HIV InfectionsCytomegalovirus Retinitis

Outcome Measures

Primary Outcomes (1)

  • Mortality Rate

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

    All patients enrolled were followed for a 17 month period or until a common study closing date

Study Arms (2)

MSL-109

EXPERIMENTAL

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

Drug: MSL-109

Placebo

PLACEBO COMPARATOR

Placebo administered intravenous infusion every 2 weeks 60 mg.

Other: Placebo

Interventions

MSL-109DRUG

60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.

Also known as: Monoclonal antibodies
MSL-109
PlaceboOTHER

60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.

Placebo

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 9400786RESULT

  • 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.

    PMID: 11919489RESULT

  • 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.

    PMID: 12232843RESULT

  • 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.

    PMID: 12559647RESULT

  • 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.

    PMID: 31042791DERIVED

MeSH Terms

Conditions

HIV InfectionsCytomegalovirus Retinitis

Interventions

sevirumabAntibodies, Monoclonal

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesEye Infections, ViralEye InfectionsCytomegalovirus InfectionsHerpesviridae InfectionsDNA Virus InfectionsEye DiseasesRetinitisRetinal Diseases

Intervention Hierarchy (Ancestors)

AntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Curtis Meinert, PhD
Organization
Johns Hopkins University
cmeinert@jhsph.edu
410-955-8198

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

September 1, 1995

Primary Completion

August 1, 1996

Study Completion

August 1, 1996

Last Updated

November 17, 2015

Results First Posted

November 17, 2015

Record last verified: 2015-07