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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Facet Biotech |
| 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: | Primary Purpose: 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 |
| Primary Completion Date: | March 1998 (Final data collection date for primary outcome measure) |
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
Show 26 Study Locations| Study Chair: | Pollard RB | |
| Study Chair: | Borucki M | |
| Study Chair: | Gnann J | |
| Study Chair: | Hirsch MS |
More Information
| ClinicalTrials.gov Identifier: | NCT00001061 History of Changes |
| Other Study ID Numbers: | ACTG 266 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Federal Government |
|
AIDS-Related Opportunistic Infections Ganciclovir Foscarnet |
Acquired Immunodeficiency Syndrome Antibodies, Monoclonal Cytomegalovirus Retinitis |
|
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Retinal Diseases Eye Diseases |
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Foscarnet Phosphonoacetic Acid Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |