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
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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.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Infections HIV Infections |
Drug: Sevirumab |
Phase 1 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Texas | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 77550 |
No publications provided
ClinicalTrials.gov Identifier: | NCT00002268 History of Changes |
Other Study ID Numbers: | 071A, Study No B102 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Immunotherapy Drug Evaluation Cytomegalovirus Infections Antibodies, Monoclonal |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Cytomegalovirus Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Immune System Diseases Herpesviridae Infections DNA Virus Infections Antibodies Antibodies, Monoclonal Antiviral Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 10, 2013