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
  Purpose

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.

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 400
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001089

  Show 36 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Erice A
Study Chair: Hirsch M
Study Chair: Polsky B
  More Information

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 August 19, 2014