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Home > "C" Clinical Trials Conditions > Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients with AIDS  Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients with AIDS
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients with AIDS
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Protein Design Labs
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - G-CSF and GM-CSF. - Antiretroviral therapy. Patients must have: - HIV infection. - First episode of CMV retinitis. - No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylaxed with oral ganciclovir and develop an episode of CMV retinitis are eligible. - No active AIDS-defining opportunistic infection or malignancy that requires nephrotoxic or myelosuppressive therapy. - Life expectancy of at least 6 months. - Consent of parent or guardian if less than 18 years of age. NOTE: - This protocol is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - PER AMENDMENT 4/25/96: Retinal detachment not scheduled for surgical repair, in all eyes meeting other eligibility criteria. (Was written as - No current retinal detachment (although old retinal detachments unrelated to HIV infection which have been repaired are permitted). - Corneal, lens, or vitreous opacification that precludes funduscopic exam. - Clinically significant pulmonary or neurologic impairment, such as intubation or coma. (Patients with a CNS mass or history of seizure disorder may enroll.) - Tuberculous, diabetic, or hypertensive retinopathy, or other retinal lesions that would interfere with measurements of response or progression. - Known hypersensitivity to the study drugs. PER AMENDMENT 4/25/96: - Presence of CMV retinal lesions that are only in areas of the retina which cannot be photographed. Concurrent Medication: Excluded: - Immunomodulators, biologic response modifiers, interferon, or investigational agents that may influence course of CMV infection. - Systemic acyclovir or any nephrotoxic agent, specifically aminoglycosides, amphotericin B, and parenteral pentamidines. - Any concomitant therapy that would preclude use of cidofovir, foscarnet or ganciclovir. Prior Medication: Excluded: PER AMENDMENT 4/25/96: - Use of IV ganciclovir, foscarnet or cidofovir within 6 months prior to study enrollment. (Was written - Ganciclovir or foscarnet for non-CMV herpes infections within 6 months prior to study entry.)
Total Enrollment: 167
Location and Contact Information:
Overall Study Official:
PollardRB, Study Chair,
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Meharry Med College
Nashville, Tennessee, 37203
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Rose Med Ctr
Denver, Colorado, 80262
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: ACTG 266;
Study Start Date:
Record last reviewed: March 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001061
Other Hiv Infections Studies:
1. A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
2. A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS
3. A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
4. A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS
5. A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Related Studies:
Other HIV Infections Clinical Trials
Other South Carolina Clinical Trials
Other West Columbia Clinical Trials
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients with AIDS
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