Cytomegalovirus InfectionsNCT00005572
A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection
An observational study of Cytomegalovirus Infections and Cytomegalovirus Retinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in United States.
Trial summary
The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections, Cytomegalovirus Retinitis, Pneumonia, Pneumocystis Carinii
- How many people
- 90 participants
- Where
- 16 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible if they:
- Are HIV positive (except Group 3b).
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Patients may be eligible for Group 1a if they:
- Have acute PCP.
- Have never received potent anti-HIV drugs or have not received potent anti-HIV drugs for at least 8 weeks prior to getting PCP.
Show all 35Show fewer
- Have a CD4 cell count below 200 cells/mm3.
- Patients may be eligible for Group 1b if they:
- Have CMV disease.
- Meet 1 of the following requirements: (1) have never received potent anti-HIV drug containing a protease inhibitor (PI) or a nonnucleoside reverse transcriptase inhibitor (NNRTI), (2) have not received potent anti-HIV drugs for at least 8 weeks before getting CMV disease, or (3) have been on stable anti-HIV therapy for at least 3 months with no new anti-HIV drugs started before CMV disease returned.
- Have a CD4 cell count below 50 cells/mm3 if patient received anti-HIV drugs at any time in the past.
- Have an eye exam (patients with CMV retinitis).
- Patients may be eligible for Group 2a if they:
- Have a history of PCP.
- Are currently receiving potent anti-HIV drugs.
- Have been enrolled in ACTG 888.
- Have been off drugs to prevent PCP for at least 48 weeks prior to study entry.
- Have not developed PCP while on potent anti-HIV drugs.
- Have a CD4 cell count above 200 cells/mm3.
- Patients may be eligible for Group 2b if they:
- Have a history of CMV retinitis.
- Are currently receiving potent anti-HIV drugs.
- Have been off drugs to prevent CMV retinitis for at least 12 weeks prior to study entry.
- Have not developed CMV retinitis while on potent anti-HIV drugs.
- Have a CD4 cell count above 50 cells/mm3.
- Have an eye exam confirming lack of CMV retinitis activity within 28 days before study entry.
- Patients may be eligible for Group 3a if they:
- Are CMV-positive.
- Have never had PCP or CMV disease.
- Have never had a CD4 count below 200 cells/mm3.
- Have never taken medications to prevent PCP or CMV disease.
- Patients may be eligible for Group 3b if they:
- Are HIV-negative.
- Are CMV-positive.
- (The lay eligibility section reflects changes in the AIDS-related infections treated.)
Who cannot join
- Patients will not be eligible if they:
- Have received a vaccine within 14 days of study entry or plan to receive one during the study.
- Have taken GM-CSF, any investigational drugs, or any drugs that might affect the immune system within 30 days of study entry or plan to take 1 of these medications during the study. (Prednisone for patients with PCP and G-CSF is allowed.)
- Abuse drugs.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Wishard Hosp
Indianapolis, Indiana, 46202
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco Gen Hosp
San Francisco, California, 941102859
Marin County Specialty Clinic
San Rafael, California, 94903
Univ of Washington
Seattle, Washington, 98104
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: Study of Pathogen-Specific Immune Responses and General Immune Competence in Opportunistic Infections
The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease. This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease. (This rationale reflects a change in the AIDS-related infections studied.)
Read the detailed description
To better understand the relationship between immunologic responses, immune reconstitution, and the occurrence of OIs, observational data need to be collected (1) in patients who present with an OI before initiation of potent antiretroviral therapy, (2) in patients with a history of such OIs who have had secondary prophylaxis or maintenance therapy withdrawn and do not develop OI recurrence after potent antiretroviral therapy, and (3) in controls who were exposed to the pathogen of interest but never were at risk for disease because their immunity was not severely compromised. Immunologic comparisons may identify correlates of protection for a group of patients who do not develop an OI after potent antiretroviral therapy-induced immune reconstitution. Conversely, a subpopulation of patients may be identified that lacks critical host factors of protection and is more likely to develop an OI after immune reconstitution, and therefore would benefit from continued prophylaxis, regardless of CD4 cell count.
This study consists of 3 groups and 8 [AS PER AMENDMENT 4/17/01: 6] subgroups. Clinical microbiological data are collected and samples are obtained for immunologic assays (pathogen-specific and general) in all groups at entry (time of OI presentation for Group 1 patients) and at 12 weeks (except Group 3b). Group 1b patients also are evaluated at 24 weeks [AS PER AMENDMENT 4/17/01: The following text has been deleted: and at the time of diagnosis of immune-recovery vitreitis, if it should develop]. [AS PER AMENDMENT 4/17/01: Once patients in Groups 1, 2, and 3a have completed the Week 12 evaluations, they will be off-study.] Blood samples, 1 to 7 days apart, for peripheral blood mononuclear cells (PBMCs), LPA, and inducible cytokine expression of interferon gamma, interleukin-2, interleukin-4, and interleukin-10 are obtained.
- Conditions
- Cytomegalovirus Infections, Cytomegalovirus Retinitis, Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Lymphocytes, Histoplasmosis, Recurrence, Cytomegalovirus Retinitis, Cell Division, Immunocompetence, Anti-HIV Agents
- Medical subject headings
- Cytomegalovirus Infections, Cytomegalovirus Retinitis, Pneumonia, Pneumocystis, HIV Infections, AIDS-Related Opportunistic Infections, Histoplasmosis, Recurrence
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
- Enrolment
- 90 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Ron D'Amico, Study chair, Beth Israel Med Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005572
- Sponsor's protocol ID
- ACTG A5067
- Other IDs
- AACTG A5067
- Status last verified
- Jun 2003
- First submitted
- 28 Apr 2000
- Last updated
- 4 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pathogen-Specific Immune Responses and General Immune Competence in Opportunistic Infections
- ClinicalTrials.gov ID
- NCT00005572
- Acronym / sponsor ID
- ACTG A5067
- Conditions
- Cytomegalovirus Infections, Cytomegalovirus Retinitis, Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Lymphocytes, Histoplasmosis, Recurrence, Cytomegalovirus Retinitis, Cell Division, Immunocompetence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 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.
The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease. This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease. (This rationale reflects a change in the AIDS-related infections studied.)
Detailed description
To better understand the relationship between immunologic responses, immune reconstitution, and the occurrence of OIs, observational data need to be collected (1) in patients who present with an OI before initiation of potent antiretroviral therapy, (2) in patients with a history of such OIs who have had secondary prophylaxis or maintenance therapy withdrawn and do not develop OI recurrence after potent antiretroviral therapy, and (3) in controls who were exposed to the pathogen of interest but never were at risk for disease because their immunity was not severely compromised. Immunologic comparisons may identify correlates of protection for a group of patients who do not develop an OI after potent antiretroviral therapy-induced immune reconstitution. Conversely, a subpopulation of patients may be identified that lacks critical host factors of protection and is more likely to develop an OI after immune reconstitution, and therefore would benefit from continued prophylaxis, regardless of CD4 cell count.
This study consists of 3 groups and 8 [AS PER AMENDMENT 4/17/01: 6] subgroups. Clinical microbiological data are collected and samples are obtained for immunologic assays (pathogen-specific and general) in all groups at entry (time of OI presentation for Group 1 patients) and at 12 weeks (except Group 3b). Group 1b patients also are evaluated at 24 weeks [AS PER AMENDMENT 4/17/01: The following text has been deleted: and at the time of diagnosis of immune-recovery vitreitis, if it should develop]. [AS PER AMENDMENT 4/17/01: Once patients in Groups 1, 2, and 3a have completed the Week 12 evaluations, they will be off-study.] Blood samples, 1 to 7 days apart, for peripheral blood mononuclear cells (PBMCs), LPA, and inducible cytokine expression of interferon gamma, interleukin-2, interleukin-4, and interleukin-10 are obtained.
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (35 listed)
- Are HIV positive (except Group 3b).
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Patients may be eligible for Group 1a if they:
- Have acute PCP.
- Have never received potent anti-HIV drugs or have not received potent anti-HIV drugs for at least 8 weeks prior to getting PCP.
Key exclusion criteria (4 listed)
- Have received a vaccine within 14 days of study entry or plan to receive one during the study.
- Have taken GM-CSF, any investigational drugs, or any drugs that might affect the immune system within 30 days of study entry or plan to take 1 of these medications during the study. (Prednisone for patients with PCP and G-CSF is allowed.)
- Abuse drugs.
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 4 Aug 2008.
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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.
Ron D'Amico study chair
Beth Israel Med Ctr
16 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 Cytomegalovirus Retinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 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 35 inclusion and 4 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 4 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 4 Aug 2008.