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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001089
• Other study ID #: ACTG 360
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 2003
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Observational Model: Natural History

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Cytomegalovirus Infections
• HIV Infections
• Infection

Locations

Country	Name	City	State
United States	Emory Univ Hosp / Pediatrics	Atlanta	Georgia
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess - West Campus	Boston	Massachusetts
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Boston Med Ctr	Boston	Massachusetts
United States	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts
United States	Montefiore Med Ctr Adolescent AIDS Program	Bronx	New York
United States	Univ of North Carolina	Chapel Hill	North Carolina
United States	Louis A Weiss Memorial Hosp	Chicago	Illinois
United States	Univ of Cincinnati	Cincinnati	Ohio
United States	Children's Hosp of Denver	Denver	Colorado
United States	Queens Med Ctr	Honolulu	Hawaii
United States	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana
United States	Indiana Univ Hosp	Indianapolis	Indiana
United States	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana
United States	Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr	Knoxville	Tennessee
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Hennepin County Med Clinic	Minneapolis	Minnesota
United States	Charity Hosp / Tulane Univ Med School	New Orleans	Louisiana
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Mem Sloan - Kettering Cancer Ctr	New York	New York
United States	St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr	New York	New York
United States	Univ of Pennsylvania at Philadelphia	Philadelphia	Pennsylvania
United States	Community Health Network Inc	Rochester	New York
United States	Univ of Rochester Medical Center	Rochester	New York
United States	Stanford at Kaiser / Kaiser Permanente Med Ctr	San Francisco	California
United States	St Louis Regional Hosp / St Louis Regional Med Ctr	St. Louis	Missouri
United States	St Paul Ramsey Med Ctr	St. Paul	Minnesota
United States	San Mateo AIDS Program / Stanford Univ	Stanford	California
United States	Harbor UCLA Med Ctr	Torrance	California
United States	Children's Hosp of Washington DC	Washington	District of Columbia
United States	Julio Arroyo	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,