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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00005572
First received: April 28, 2000
Last updated: July 31, 2008
Last verified: June 2003
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 90
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therapy, (2) in patients with a history of such OIs who have had secondary prophylaxis or maintenance therapy withdrawn and do not develop OI recurrence after potent antiretroviral therapy, and (3) in controls who were exposed to the pathogen of interest but never were at risk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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

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.
  • 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.)

Exclusion Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005572

Locations
United States, California
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
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
Wishard Hosp
Indianapolis, Indiana, United States, 46202
Methodist Hosp of Indiana / Life Care Clinic
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
Sponsors and Collaborators
Investigators
Study Chair: Ron D'Amico Beth Israel Med Ctr
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005572     History of Changes
Other Study ID Numbers: ACTG A5067, AACTG A5067
Study First Received: April 28, 2000
Last Updated: July 31, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Lymphocytes
Histoplasmosis
Recurrence
Cytomegalovirus Retinitis
Cell Division
Immunocompetence
Anti-HIV Agents

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
Cytomegalovirus Infections
Cytomegalovirus Retinitis
HIV Infections
Infection
Opportunistic Infections
Pneumonia
Pneumonia, Pneumocystis
Retinitis
DNA Virus Infections
Eye Diseases
Eye Infections
Eye Infections, Viral
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lung Diseases
Lung Diseases, Fungal
Mycoses
Parasitic Diseases
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Retinal Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral

ClinicalTrials.gov processed this record on October 21, 2014