A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
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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.
Condition |
---|
Cytomegalovirus Infections HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Natural History |
Official Title: | Human Immunodeficiency Virus (HIV) and Cytomegalovirus (CMV) Viral Burden and Development of CMV End-Organ Disease: A Prospective Study in HIV-Infected Individuals. |
Estimated Enrollment: | 400 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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Study Chair: | Erice A | |
Study Chair: | Hirsch M | |
Study Chair: | Polsky B |
No publications provided
ClinicalTrials.gov Identifier: | NCT00001089 History of Changes |
Other Study ID Numbers: | ACTG 360 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Prospective Studies HIV-1 Cytomegalovirus Cytomegalovirus Infections |
Acquired Immunodeficiency Syndrome Anti-HIV Agents Viral Load Multiple Organ Failure |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Cytomegalovirus Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Herpesviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on March 10, 2013