A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
- Conditions
- Cytomegalovirus InfectionsHIV Infections
- Registration Number
- NCT00001089
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Louis A Weiss Memorial Hosp
🇺🇸Chicago, Illinois, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸St. Louis, Missouri, United States
St Paul Ramsey Med Ctr
🇺🇸St. Paul, Minnesota, United States
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Community Health Network Inc
🇺🇸Rochester, New York, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
🇺🇸New York, New York, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
🇺🇸Knoxville, Tennessee, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Hennepin County Med Clinic
🇺🇸Minneapolis, Minnesota, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States