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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) PDL BioPharma, Inc. |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001061 |
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 |
MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
Drug Information available for: | Ganciclovir Ganciclovir sodium Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid Sevirumab |
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.
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:
Show 26 Study Locations |
National Institute of Allergy and Infectious Diseases (NIAID) |
PDL BioPharma, Inc. |
Study Chair: | Pollard RB | |
Study Chair: | Borucki M | |
Study Chair: | Gnann J | |
Study Chair: | Hirsch MS |
Click here for more information about ganciclovir 
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Borucki M, Spritzler J, Gnann J, Hirsch M, Nokta M, Aweeka F, Pollard R. A phase II double masked, 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 newly diagnosed cytomegalovirus (CMV) retinitis in ACTG 266. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:154 (abstract no 460)
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[No authors listed] CMV retinitis study aborted. GMHC Treat Issues. 1996 Sep;10(9):8. No abstract available.
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Study ID Numbers: | ACTG 266 |
First Received: | November 2, 1999 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00001061 |
Health Authority: | United States: Federal Government |
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