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

Last updated: June 23, 2005
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Completed

Phase

N/A

Condition

Hiv Infections

Cytomegalovirus Infections

Treatment

N/A

Clinical Study ID

NCT00001089
ACTG 360
  • Ages > 13
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 400
Study Start date:
Estimated Completion Date:

Study 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.

Connect with a study center

  • Univ of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Los Angeles County - USC Med Ctr

    Los Angeles, California 90033
    United States

    Site Not Available

  • UCLA CARE Ctr

    Los Angeles, California 90095
    United States

    Site Not Available

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California 900331079
    United States

    Site Not Available

  • Stanford at Kaiser / Kaiser Permanente Med Ctr

    San Francisco, California 94115
    United States

    Site Not Available

  • San Mateo AIDS Program / Stanford Univ

    Stanford, California 943055107
    United States

    Site Not Available

  • Harbor UCLA Med Ctr

    Torrance, California 90502
    United States

    Site Not Available

  • Children's Hosp of Denver

    Denver, Colorado 802181088
    United States

    Site Not Available

  • Children's Hosp of Washington DC

    Washington, District of Columbia 200102916
    United States

    Site Not Available

  • Univ of Miami School of Medicine

    Miami, Florida 331361013
    United States

    Site Not Available

  • Emory Univ Hosp / Pediatrics

    Atlanta, Georgia 30306
    United States

    Site Not Available

  • Queens Med Ctr

    Honolulu, Hawaii 96816
    United States

    Site Not Available

  • Louis A Weiss Memorial Hosp

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Division of Inf Diseases/ Indiana Univ Hosp

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana Univ Hosp

    Indianapolis, Indiana 462025250
    United States

    Site Not Available

  • Methodist Hosp of Indiana / Life Care Clinic

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Charity Hosp / Tulane Univ Med School

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Johns Hopkins Hosp

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Boston Med Ctr

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Harvard (Massachusetts Gen Hosp)

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Hennepin County Med Clinic

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • St Paul Ramsey Med Ctr

    St. Paul, Minnesota 55101
    United States

    Site Not Available

  • St Louis Regional Hosp / St Louis Regional Med Ctr

    St. Louis, Missouri 63112
    United States

    Site Not Available

  • Montefiore Med Ctr Adolescent AIDS Program

    Bronx, New York 10467
    United States

    Site Not Available

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York 10016
    United States

    Site Not Available

  • Mem Sloan - Kettering Cancer Ctr

    New York, New York 10021
    United States

    Site Not Available

  • St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr

    New York, New York 10021
    United States

    Site Not Available

  • Community Health Network Inc

    Rochester, New York 14642
    United States

    Site Not Available

  • Univ of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Univ of North Carolina

    Chapel Hill, North Carolina 275997215
    United States

    Site Not Available

  • Univ of Cincinnati

    Cincinnati, Ohio 452670405
    United States

    Site Not Available

  • Univ of Pennsylvania at Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Julio Arroyo

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr

    Knoxville, Tennessee 37920
    United States

    Site Not Available

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