A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria

HIV Infections Clinical Trial

Official title:

A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002268
• Other study ID #: 071A
• Secondary ID: Study No B102
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1991
• 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, tolerance, and potential in vivo antiviral effects of five dosage levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109; formerly SDZ 89-109) when administered once every 2 weeks for a total of 12 doses to patients with either AIDS or eligible AIDS-related complex (ARC) and with culture proven evidence of CMV viremia and/or viruria. Sandoglobulin will be employed as a comparative control.

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).

• Acyclovir.

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

• Trimethoprim / sulfamethoxazole (TMP / SMX).

• Pyrimethamine / sulfadoxine.

• Inhaled pentamidine.

• Amphotericin B.

• Ketoconazole.

• Flucytosine (5-FC).

• Antituberculosis therapy.

• Recombinant human erythropoietin.

• Recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF).

• Recombinant human interferon alfa 2 for AIDS-related Kaposi's sarcoma.

Patients must have:

• AIDS or be HIV positive with CD4 lymphocyte counts below 200 cells/mm3 and be receiving prophylaxis for Pneumocystis carinii pneumonia (PCP) (with or without prophylaxis for another opportunistic infection), but have no prior medical history of an opportunistic infection.

• 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.

• Positive culture results documenting the presence of cytomegalovirus (CMV) viremia and/or viruria.

• 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 ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.

• Any other experimental antiviral therapy.

• Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).

Patients with the following are excluded:

• Any significant organ system dysfunction as described in Exclusion co-existing conditions.

• Previous history of or evidence of idiopathic thrombocytopenia purpura, agammaglobulinemia, or hypogammaglobulinemia.

• Any other severe concomitant clinical condition.

• Documented, active cytomegalovirus (CMV) disease (tissue or organ invasion/dysfunction) at baseline. To this end, baseline indirect funduscopy (to detect and exclude patients with peripheral CMV retinitis) will be performed.

Prior Medication:

Excluded within 2 weeks of study entry:

• Therapy with ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol.

• Any other experimental antiviral therapy.

• Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol).

• 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
• Communicable Diseases
• Cytomegalovirus Infections
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Sevirumab

Locations

Country	Name	City	State
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Univ TX Galveston Med Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz Inc.

Country where clinical trial is conducted

United States,