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.
1 other identifier
observational
400
1 country
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 2003
November 2, 1999
June 23, 2005
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, United States
Queens Med Ctr
Honolulu, Hawaii, 96816, 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
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, 10021, United States
Community Health Network Inc
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Erice A
- STUDY CHAIR
Hirsch M
- STUDY CHAIR
Polsky B
Study Design
- Study Type
- observational
- Observational Model
- NATURAL HISTORY
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2003-02