A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis

HIV Infections Clinical Trial

Official title:

A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002016
• Other study ID #: 071B
• Secondary ID: Study No B103
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV retinitis. In addition for those patients with positive CMV cultures upon entry into this trial a preliminary attempt will be made to assess the potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ MSL-109.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Zidovudine (AZT) < 600 mg/day.

• Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection.

• Trimethoprim / sulfamethoxazole (TMP / SMX).

• Pyrimethamine / sulfadoxine.

• Aerosolized pentamidine.

• Ketoconazole.

• Flucytosine (5-FC).

• Antituberculosis therapy.

Concurrent Treatment:

Allowed:

• Maintenance phase of ganciclovir (DHPG) therapy.

Patients must have:

• AIDS with documented ophthalmologic findings consistent with cytomegalovirus (CMV) retinitis whose retinal lesions are less than 750 microns from the fovea and who have visual symptoms of CMV retinitis.

• Completed the treatment induction phase with ganciclovir (DHPG) and be about to participate in the maintenance phase DHPG therapy.

• Expected survival of = or > 6 months.

• Willingness and ability to give written informed consent. A copy of the signed and witnessed consent form must be maintained with the investigator's study files.

• Seropositive for the presence of circulating anti-CMV immunoglobulin.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Significant pulmonary dysfunction.

• Uncontrolled or unstable diabetes.

• Significant cardiovascular disease including uncontrolled hypertension, congestive heart failure, cardiac arrhythmia, angina pectoris, or a history of myocardial infarction within one year of entry into the study.

• Coagulation or hemorrhagic disorders.

• Any active severe opportunistic infection.

Concurrent Medication:

Excluded:

• Therapy with amphotericin B or fluconazole.

• Any other investigational drug.

• Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating-factor (GM-CSF), erythropoietin alpha, or any interleukin.

Patients with the following are excluded:

• Any significant organ system dysfunction as described in Exclusion Co-existing Conditions.

• Any other severe concomitant clinical condition.

Prior Medication:

Excluded within 2 weeks of study entry:

• Therapy with amphotericin B or fluconazole.

• Any other investigational drug.

• Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating factor (GM-CSF), erythropoietin alpha, or any interleukin.

• Excluded:

• Prior treatment with monoclonal antibodies derived from any animal species.

Prior Treatment:

Excluded within 2 weeks of study entry:

• Major surgery.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cytomegalovirus Retinitis
• HIV Infections
• Immunologic Deficiency Syndromes
• Retinitis

Intervention

Drug:
• Sevirumab

Locations

Country	Name	City	State
United States	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts
United States	Univ TX Galveston Med Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tolpin M, Pollard R, Tierney M, Nokta M, Wood D, Hirsch M. Combination therapy of cytomegalovirus (CMV) retinitis with a human monoclonal anti-CMV antibody (SDZ MSL 109) and either ganciclovir (DHPG) or foscarnet (PFA). Int Conf AIDS. 1993 Jun 6-11;9(1):54 (abstract no WS-B11-2)