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
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ClinicalTrials.gov Identifier: NCT00002016 |
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 Retinitis HIV Infections | Drug: Sevirumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
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 |


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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) < 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.

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): NCT00002016
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, Texas | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 77550 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002016 History of Changes |
Other Study ID Numbers: |
071B Study No B103 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 1993 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis Ganciclovir Cytomegalovirus |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antibodies, Monoclonal |
Additional relevant MeSH terms:
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |