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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00005572 |
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.)
Condition |
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Cytomegalovirus Infections Cytomegalovirus Retinitis Pneumonia, Pneumocystis Carinii HIV Infections |
Study Type: | Observational |
Official Title: | Study of Pathogen-Specific Immune Responses and General Immune Competence in Opportunistic Infections |
Estimated Enrollment: | 90 |
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therapy, (2) in patients with a history of such OIs who have had secondary prophylaxis or maintenance therapy withdrawn and do not develop OI recurrence after potent antiretroviral therapy, and (3) in controls who were exposed to the pathogen of interest but never were at risk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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients may be eligible if they:
Exclusion Criteria
Patients will not be eligible if they:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
Marin County Specialty Clinic | |
San Rafael, California, United States, 94903 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Methodist Hosp of Indiana / Life Care Clinic | |
Indianapolis, Indiana, United States, 46202 | |
Wishard Hosp | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Pennsylvania | |
Univ of Pennsylvania at Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | Ron D'Amico | Beth Israel Med Ctr |
Study ID Numbers: | ACTG A5067, AACTG A5067 |
Study First Received: | April 28, 2000 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00005572 History of Changes |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Lymphocytes Histoplasmosis Recurrence |
Cytomegalovirus Retinitis Cell Division Immunocompetence Anti-HIV Agents |
Opportunistic Infections Sexually Transmitted Diseases, Viral Histoplasmosis Retinitis Cytomegalovirus Pneumonia, Pneumocystis Mycoses Respiratory Tract Diseases Respiratory Tract Infections AIDS-Related Opportunistic Infections Cytomegalic Inclusion Disease Cytomegalovirus Infections Parasitic Diseases Retroviridae Infections Retinal Diseases |
Lung Diseases, Fungal Anti-HIV Agents Eye Diseases Eye Infections Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Recurrence Herpesviridae Infections Virus Diseases Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases DNA Virus Infections |
Opportunistic Infections Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Retinitis Infection Mycoses Pneumonia, Pneumocystis Respiratory Tract Diseases Respiratory Tract Infections Cytomegalovirus Infections Parasitic Diseases Retroviridae Infections Retinal Diseases Lung Diseases, Fungal |
RNA Virus Infections Eye Infections, Viral Immune System Diseases Eye Diseases Eye Infections Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Lentivirus Infections |