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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ClinicalTrials.gov Identifier: NCT00002268 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cytomegalovirus Infections HIV Infections | Drug: Sevirumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002268
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 |
ClinicalTrials.gov Identifier: | NCT00002268 History of Changes |
Other Study ID Numbers: |
071A Study No B102 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 1991 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Immunotherapy Drug Evaluation Cytomegalovirus Infections Antibodies, Monoclonal |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Cytomegalovirus Infections Viremia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases |
Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Antibodies Immunoglobulins Antibodies, Monoclonal Antiviral Agents Immunologic Factors Physiological Effects of Drugs Anti-Infective Agents |