Cytomegalovirus InfectionsNCT00001089
A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
An observational study of Cytomegalovirus Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 36 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cytomegalovirus Infections, HIV Infections
- How many people
- 400 participants
- Where
- 36 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Boston Med Ctr
Boston, Massachusetts, 02118
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Children's Hosp of Denver
Denver, Colorado, 802181088
Queens Med Ctr
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Miami School of Medicine
Miami, Florida, 331361013
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, 10021
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Community Health Network Inc
Rochester, New York, 14642
Univ of Rochester Medical Center
Rochester, New York, 14642
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
Harbor UCLA Med Ctr
Torrance, California, 90502
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
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.
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.
Read the 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.
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Keywords
- Prospective Studies, HIV-1, Cytomegalovirus, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Anti-HIV Agents, Viral Load, Multiple Organ Failure
- Medical subject headings
- Cytomegalovirus Infections, HIV Infections, Acquired Immunodeficiency Syndrome, Multiple Organ Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Enrolment
- 400 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Erice A, Study chairHirsch M, Study chairPolsky B, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001089
- Sponsor's protocol ID
- ACTG 360
- Status last verified
- Feb 2003
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00001089
- Acronym / sponsor ID
- ACTG 360
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Keywords
- Prospective Studies, HIV-1, Cytomegalovirus, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Anti-HIV Agents, Viral Load, Multiple Organ Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Natural history
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Documented HIV-1 infection.
- Documented evidence of CD4 count <= 50 cells/mm3 in the previous 24 months.
- Presence of serum CMV IgG antibodies.
Key exclusion criteria (6 listed)
- Ocular media opacities that preclude adequate visualization of the fundi.
- History of CMV end-organ disease.
- Any pre-existing necrotizing retinopathy that may interfere with a subsequent diagnosis of CMV retinitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erice A study chair
Hirsch M study chair
Polsky B study chair
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.