- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00001089
A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
Human Immunodeficiency Virus (HIV) and Cytomegalovirus (CMV) Viral Burden and Development of CMV End-Organ Disease: A Prospective Study in HIV-Infected Individuals.
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- Univ of Alabama at Birmingham
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California
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Los Angeles, California, Vereinigte Staaten, 90095
- UCLA CARE Ctr
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Los Angeles, California, Vereinigte Staaten, 90033
- Los Angeles County - USC Med Ctr
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Los Angeles, California, Vereinigte Staaten, 900331079
- Univ of Southern California / LA County USC Med Ctr
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San Francisco, California, Vereinigte Staaten, 94115
- Stanford at Kaiser / Kaiser Permanente Med Ctr
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Stanford, California, Vereinigte Staaten, 943055107
- San Mateo AIDS Program / Stanford Univ
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Torrance, California, Vereinigte Staaten, 90502
- Harbor UCLA Med Ctr
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Colorado
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Denver, Colorado, Vereinigte Staaten, 802181088
- Children's Hosp of Denver
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 200102916
- Children's Hosp of Washington DC
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Florida
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Miami, Florida, Vereinigte Staaten, 331361013
- Univ of Miami School of Medicine
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30306
- Emory Univ Hosp / Pediatrics
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Hawaii
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Honolulu, Hawaii, Vereinigte Staaten, 96816
- Queens Med Ctr
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60640
- Louis A Weiss Memorial Hosp
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Charity Hosp / Tulane Univ Med School
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21287
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Harvard (Massachusetts Gen Hosp)
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Boston, Massachusetts, Vereinigte Staaten, 02118
- Boston Med Ctr
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess Med Ctr
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55415
- Hennepin County Med Clinic
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St. Paul, Minnesota, Vereinigte Staaten, 55101
- St Paul Ramsey Med Ctr
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Missouri
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St. Louis, Missouri, Vereinigte Staaten, 63112
- St Louis Regional Hosp / St Louis Regional Med Ctr
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New York
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Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Med Ctr Adolescent AIDS Program
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New York, New York, Vereinigte Staaten, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Vereinigte Staaten, 10021
- Mem Sloan - Kettering Cancer Ctr
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New York, New York, Vereinigte Staaten, 10021
- St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
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Rochester, New York, Vereinigte Staaten, 14642
- Univ of Rochester Medical Center
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Rochester, New York, Vereinigte Staaten, 14642
- Community Health Network Inc
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 275997215
- Univ of North Carolina
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 452670405
- Univ of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Univ of Pennsylvania at Philadelphia
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South Carolina
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West Columbia, South Carolina, Vereinigte Staaten, 29169
- Julio Arroyo
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37920
- Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Polsky B
- Studienstuhl: Erice A
Studienaufzeichnungsdaten
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ACTG 360
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