Clinical trial NCT00001089: A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus Infections
HIV Infections
Keywords: Prospective Studies
HIV-1
Cytomegalovirus
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Anti-HIV Agents
Viral Load
Multiple Organ Failure
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief 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.

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 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.

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