A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection

Completed

• Conditions: Cytomegalovirus Infections; Cytomegalovirus Retinitis; Pneumonia, Pneumocystis Carinii; HIV Infections

• Registration Number: NCT00005572
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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. 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therapy, (2) in patients with a history of such OIs who have had secondary prophylaxis or maintenance therapy withdrawn and do not develop OI recurrence after potent antiretroviral therapy, and (3) in controls who were exposed to the pathogen of interest but never were at risk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 Timeline

• Study First Submitted: 2000-04-28
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2003-06
• Last Update Submitted: 2008-07-31
• Last Update Posted: 2008-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (16)

Univ of California / San Diego Treatment Ctr; 🇺🇸 San Diego, California, United States

San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Rush Presbyterian - Saint Luke's Med Ctr; 🇺🇸 Chicago, Illinois, United States

Methodist Hosp of Indiana / Life Care Clinic; 🇺🇸 Indianapolis, Indiana, United States

Marin County Specialty Clinic; 🇺🇸 San Rafael, California, United States

Julio Arroyo; 🇺🇸 West Columbia, South Carolina, United States

Univ of Southern California / LA County USC Med Ctr; 🇺🇸 Los Angeles, California, United States

Children's Mem Hosp Family Cln / Northwestern Univ Med Schl; 🇺🇸 Chicago, Illinois, United States

Bellevue Hosp / New York Univ Med Ctr; 🇺🇸 New York, New York, United States

Johns Hopkins Hosp; 🇺🇸 Baltimore, Maryland, United States

Univ of Washington; 🇺🇸 Seattle, Washington, United States

Beth Israel Med Ctr; 🇺🇸 New York, New York, United States

Univ of Colorado Health Sciences Ctr; 🇺🇸 Denver, Colorado, United States

Wishard Hosp; 🇺🇸 Indianapolis, Indiana, United States

Univ of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Univ of Pennsylvania at Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States