Clinical trial NCT00000836: A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Official title: A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
Antibodies, Monoclonal
Cytomegalovirus Retinitis
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV retinitis.

Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.

Detailed description: Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.

Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.

Eligibility criteria: Inclusion Criteria

Concurrent Medication: Required:

* Primary CMV treatment.

Patients must have:

* AIDS.
* Active CMV retinitis.
* At least one photographable lesion of one-quarter or more optic disc area in size.
* Undergoing primary treatment for CMV retinitis that is not contraindicated with MSL 109.
* Visual acuity in at least one eye of 3 or more letters on Early Treatment Diabetic Retinopathy Study ( ETDRS ) chart at 1 meter distance ( Snellen equivalent 5/200 ). Note:
* Exceptions may be made if visual acuity impairment is possibly reversible and there is at least light perception in that eye.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Retinal detachment not scheduled for surgical repair.
* Media opacity that precludes visualization of the fundus.
* Active medical problems sufficient to hinder study compliance.

Concurrent Medication:

Excluded:

* IVIG.
* CMV immune globulin ( CMVIG ).
* Interferon alpha.
* Interferon gamma.
* Interleukin-2 ( IL-2 ).

Drug or alcohol abuse sufficient to hinder study compliance.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD - Shiley Eye Ctr / SOCA
state: California
city: Los Angeles
country: United States
facility: UCLA - Jules Stein Eye Institute / SOCA
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Chicago
country: United States
facility: Northwestern Univ / SOCA
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hosp / SOCA
state: Maryland
city: New York
country: United States
facility: New York Univ Med Ctr / SOCA
state: New York
Study officials:
References: