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Human Immunodeficiency Virus (HIV) and Cytomegalovirus (CMV) Viral Burden and Development of CMV End-Organ Disease: A Prospective Study in HIV-Infected Individuals.

13 Years
Not Enrolling
Cytomegalovirus Infections, HIV Infections

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Trial Information

Human Immunodeficiency Virus (HIV) and Cytomegalovirus (CMV) Viral Burden and Development of CMV End-Organ Disease: A Prospective Study in HIV-Infected Individuals.

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

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- 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.

Type of Study:


Study Design:

Observational Model: Natural History

Principal Investigator

Erice A

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 360



Start Date:

Completion Date:

Related Keywords:

  • Cytomegalovirus Infections
  • HIV Infections
  • Prospective Studies
  • HIV-1
  • Cytomegalovirus
  • Cytomegalovirus Infections
  • Acquired Immunodeficiency Syndrome
  • Anti-HIV Agents
  • Viral Load
  • Multiple Organ Failure
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Cytomegalovirus Infections



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