A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
NCT ID: NCT00001089
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NATURAL_HISTORY
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Erice A
Role: STUDY_CHAIR
Hirsch M
Role: STUDY_CHAIR
Polsky B
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States
Harbor UCLA Med Ctr
Torrance, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Queens Med Ctr
Honolulu, Hawaii, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States
Boston Med Ctr
Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, United States
Community Health Network Inc
Rochester, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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ACTG 360
Identifier Type: -
Identifier Source: org_study_id