HIV Infections Clinical Trial
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.)
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a history of such OIs who have had secondary prophylaxis or maintenance therapy withdrawn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.
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