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A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001089
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2003

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00001089 on ClinicalTrials.gov Archive Site
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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.

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.

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.

Observational
Observational Model: Natural History
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  • Cytomegalovirus Infections
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001089
ACTG 360
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National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Erice A
Study Chair: Hirsch M
Study Chair: Polsky B
National Institute of Allergy and Infectious Diseases (NIAID)
February 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP