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A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients Clinical research trials and A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients clinical trial. Human subjects often receive the most effective healthcare possible for their A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients  A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To define relationships between 1) HIV load and risk of CMV disease, 2) CMV load and the risk of developing CMV disease, and 3) CMV load and HIV load. To establish threshold CMV and HIV load values in peripheral blood fractions that are associated with development of CMV end-organ disease. To define the natural history of CMV diseases in the context of highly active antiretroviral therapy (HAART). Establishment of threshold CMV and HIV load values associated with CMV disease would facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom targeted prophylactic interventions to prevent CMV disease would be indicated. These studies would also further the understanding of the natural history of CMV disease within the context of AIDS. Natural history studies conducted prior to the advent of highly active antiretroviral therapy (HAART; i.e., 3-drug regimens that include HIV reverse transcriptase and protease inhibitors) have demonstrated that the risk for developing CMV disease increases with progression of HIV disease and with declining CD4 counts. Presently the need exists to define the natural history of CMV disease in patients with AIDS within the context of HAART.
Details: Establishment of threshold CMV and HIV load values associated with CMV disease would facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom targeted prophylactic interventions to prevent CMV disease would be indicated. These studies would also further the understanding of the natural history of CMV disease within the context of AIDS. Natural history studies conducted prior to the advent of highly active antiretroviral therapy (HAART; i.e., 3-drug regimens that include HIV reverse transcriptase and protease inhibitors) have demonstrated that the risk for developing CMV disease increases with progression of HIV disease and with declining CD4 counts. Presently the need exists to define the natural history of CMV disease in patients with AIDS within the context of HAART. In this prospective observational study, HIV-infected patients who are CMV-seropositive with no clinical symptoms of CMV disease at entry are followed for three years or until the diagnosis of CMV end-organ disease or death, whichever comes first. Clinical evaluations are performed at baseline and every 8 weeks. Blood samples for virologic studies are taken every 16 weeks.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antivirals with anti-CMV activity (such as acyclovir, ganciclovir, valacyclovir, valganciclovir, foscarnet, etc.) for reasons other than treatment of CMV disease. - Antivirals for prophylaxis or treatment of other herpesvirus infections. Patients must have: - Documented HIV-1 infection. - Documented evidence of CD4 count <= 50 cells/mm3 in the previous 24 months. - Presence of serum CMV IgG antibodies. - No history of CMV end-organ disease or evidence of active CMV disease prior to study entry. NOTE: A history of positive CMV urine or blood cultures is acceptable as long as it has been determined that the patient does not have CMV end-organ disease. - Signed, informed consent of parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Ocular media opacities that preclude adequate visualization of the fundi. Patients with the following prior conditions are excluded: - History of CMV end-organ disease. - Any pre-existing necrotizing retinopathy that may interfere with a subsequent diagnosis of CMV retinitis.
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
EriceA, Study Chair,
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City, New York, 10021
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Community Health Network Inc
Rochester, New York, 14642
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: ACTG 360;
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001089
Other Hiv Infections Studies:
1. Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women with Chronic Infections
2. Immune Response to Cytomegalovirus
3. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
4. A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection
5. Inflammation, Infection, and Future Cardiovascular Risk
Related Studies:
Other HIV Infections Clinical Trials
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Other Los Angeles Clinical Trials
A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
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