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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.


N/A
13 Years
N/A
Not Enrolling
Both
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
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.

Inclusion 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.

Type of Study:

Observational

Study Design:

Observational Model: Natural History

Principal Investigator

Erice A

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 360

NCT ID:

NCT00001089

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

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
Los Angeles County - USC Med CtrLos Angeles, California  90033
UCLA CARE CtrLos Angeles, California  90095
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, California  94115
Harbor UCLA Med CtrTorrance, California  90502
Univ of Miami School of MedicineMiami, Florida  331361013
Indiana Univ HospIndianapolis, Indiana  462025250
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Beth Israel Deaconess Med CtrBoston, Massachusetts  02215
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Boston Med CtrBoston, Massachusetts  02118
Univ of North CarolinaChapel Hill, North Carolina  275997215
Univ of Tennessee / E Tennessee Comprehensive Hemophilia CtrKnoxville, Tennessee  37920
Johns Hopkins HospBaltimore, Maryland  21287
Charity Hosp / Tulane Univ Med SchoolNew Orleans, Louisiana  70112
St Louis Regional Hosp / St Louis Regional Med CtrSt Louis, Missouri  63112
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Hennepin County Med ClinicMinneapolis, Minnesota  55415
St Paul Ramsey Med CtrSt Paul, Minnesota  55101
Univ of CincinnatiCincinnati, Ohio  452670405
Univ of Pennsylvania at PhiladelphiaPhiladelphia, Pennsylvania  19104
San Mateo AIDS Program / Stanford UnivStanford, California  943055107
Louis A Weiss Memorial HospChicago, Illinois  60640
Methodist Hosp of Indiana / Life Care ClinicIndianapolis, Indiana  46202
Montefiore Med Ctr Adolescent AIDS ProgramBronx, New York  10467
Queens Med CtrHonolulu, Hawaii  96816
Division of Inf Diseases/ Indiana Univ HospIndianapolis, Indiana  46202
St Vincent's Hosp / Mem Sloan-Kettering Cancer CtrNew York, New York  10021
Community Health Network IncRochester, New York  14642
Children's Hosp of DenverDenver, Colorado  802181088
Children's Hosp of Washington DCWashington, District of Columbia  200102916
Emory Univ Hosp / PediatricsAtlanta, Georgia  30306