A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
Completed
Conditions studied: Cytomegalovirus Infections, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001089
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 400
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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