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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
PDL BioPharma, Inc. |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001061 |
Purpose
To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers.
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Sevirumab Drug: Foscarnet sodium Drug: Ganciclovir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II, Double-Masked, Randomized, Placebo-Controlled Evaluation of Standard Therapy vs. Standard Therapy Combined With Human Monoclonal Anti-Cytomegalovirus Antibody (MSL 109) in the Therapy of AIDS Patients With Cytomegalovirus (CMV) Retinitis |
| Estimated Enrollment: | 167 |
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days, then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression. Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance. They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks. Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs. AS PER AMENDMENT 11/29/96: Enrollment onto the current study has been discontinued. To study the enhancement of humoral immunity, a high-dose cohort has been added. Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before. Randomization is weighted 2:1 in favor of high-dose MSL 109. Interim analyses will be performed to provide for early discontinuation, as indicated. Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
PER AMENDMENT 4/25/96:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded: PER AMENDMENT 4/25/96:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
| San Jose, California, United States, 951282699 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| Rose Med Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Hawaii | |
| Queens Med Ctr | |
| Honolulu, Hawaii, United States, 96816 | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| SUNY / State Univ of New York | |
| Syracuse, New York, United States, 13210 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Saint Christopher's Hosp for Children | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Tennessee | |
| Meharry Med College | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| Study Chair: | Pollard RB | |
| Study Chair: | Borucki M | |
| Study Chair: | Gnann J | |
| Study Chair: | Hirsch MS |
More Information
| Study ID Numbers: | ACTG 266 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001061 History of Changes |
| Health Authority: | United States: Federal Government |
|
AIDS-Related Opportunistic Infections Ganciclovir Foscarnet |
Acquired Immunodeficiency Syndrome Antibodies, Monoclonal Cytomegalovirus Retinitis |
|
Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Phosphonoacetic Acid Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Retinitis Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors Retinal Diseases |
RNA Virus Infections Immune System Diseases Eye Infections, Viral Eye Diseases Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Enzyme Inhibitors Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections |