Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS

NCT00001061 | Completed Phase 2

• 2 other identifiers: ACTG 26611242
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 20

Brief Summary

To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers. Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.

Conditions

Cytomegalovirus Retinitis; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Ganciclovir; Foscarnet; Acquired Immunodeficiency Syndrome; Antibodies, Monoclonal; Cytomegalovirus Retinitis

Interventions

Sevirumab DRUG

Foscarnet sodium DRUG

Ganciclovir DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• G-CSF and GM-CSF.
• Antiretroviral therapy.
• Patients must have:
• HIV infection.
• First episode of CMV retinitis.
• No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylaxed with oral ganciclovir and develop an episode of CMV retinitis are eligible.
• No active AIDS-defining opportunistic infection or malignancy that requires nephrotoxic or myelosuppressive therapy.
• Life expectancy of at least 6 months.
• Consent of parent or guardian if less than 18 years of age.
• NOTE:
• This protocol is approved for prisoner participation.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• PER AMENDMENT 4/25/96: Retinal detachment not scheduled for surgical repair, in all eyes meeting other eligibility criteria. (Was written as - No current retinal detachment (although old retinal detachments unrelated to HIV infection which have been repaired are permitted).
• Corneal, lens, or vitreous opacification that precludes funduscopic exam.
• Clinically significant pulmonary or neurologic impairment, such as intubation or coma. (Patients with a CNS mass or history of seizure disorder may enroll.)
• Tuberculous, diabetic, or hypertensive retinopathy, or other retinal lesions that would interfere with measurements of response or progression.
• Known hypersensitivity to the study drugs.
• PER AMENDMENT 4/25/96:
• Presence of CMV retinal lesions that are only in areas of the retina which cannot be photographed.
• Concurrent Medication:
• Excluded:
• Immunomodulators, biologic response modifiers, interferon, or investigational agents that may influence course of CMV infection.
• Systemic acyclovir or any nephrotoxic agent, specifically aminoglycosides, amphotericin B, and parenteral pentamidines.
• Any concomitant therapy that would preclude use of cidofovir, foscarnet or ganciclovir.
• Prior Medication:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Facet Biotech: collaborator

Study Sites (20)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

USC CRS

Los Angeles, California, 900331079, United States

Location

Santa Clara Valley Med. Ctr.

San Jose, California, 951282699, United States

Location

Stanford CRS

Stanford, California, 943055107, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 331361013, United States

Location

Queens Med. Ctr.

Honolulu, Hawaii, 96816, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 462025250, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, 02215, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 452670405, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Borucki M, Spritzler J, Gnann J, Hirsch M, Nokta M, Aweeka F, Pollard R. A phase II double masked, placebo-controlled evaluation of standard therapy vs standard therapy combined with human monoclonal anti-cytomegalovirus antibody (MSL-109) in the therapy of AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis in ACTG 266. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:154 (abstract no 460)

  BACKGROUND

• CMV retinitis study aborted. GMHC Treat Issues. 1996 Sep;10(9):8.

  PMID: 11363844 BACKGROUND

• Borucki MJ, Spritzler J, Asmuth DM, Gnann J, Hirsch MS, Nokta M, Aweeka F, Nadler PI, Sattler F, Alston B, Nevin TT, Owens S, Waterman K, Hubbard L, Caliendo A, Pollard RB; AACTG 266 Team. A phase II, double-masked, randomized, placebo-controlled evaluation of a human monoclonal anti-Cytomegalovirus antibody (MSL-109) in combination with standard therapy versus standard therapy alone in the treatment of AIDS patients with Cytomegalovirus retinitis. Antiviral Res. 2004 Nov;64(2):103-11. doi: 10.1016/j.antiviral.2004.06.012.

  PMID: 15498605 RESULT

MeSH Terms

Conditions

Cytomegalovirus Retinitis; HIV Infections; AIDS-Related Opportunistic Infections; Multiple Acyl Coenzyme A Dehydrogenase Deficiency; Acquired Immunodeficiency Syndrome

Interventions

sevirumab; Foscarnet; Ganciclovir

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Eye Diseases; Retinitis; Retinal Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pollard RB

  STUDY CHAIR

• Borucki M

  STUDY CHAIR

• Gnann J

  STUDY CHAIR

• Hirsch MS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 1998
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (20)