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

Primary Purpose

Cytomegalovirus Infections, Cytomegalovirus Retinitis, Pneumonia, Pneumocystis Carinii

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cytomegalovirus Infections focused on measuring AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Lymphocytes, Histoplasmosis, Recurrence, Cytomegalovirus Retinitis, Cell Division, Immunocompetence, Anti-HIV Agents

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Univ of Southern California / LA County USC Med Ctr
  • Univ of California / San Diego Treatment Ctr
  • San Francisco Gen Hosp
  • Marin County Specialty Clinic
  • Univ of Colorado Health Sciences Ctr
  • Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Methodist Hosp of Indiana / Life Care Clinic
  • Wishard Hosp
  • Johns Hopkins Hosp
  • Beth Israel Med Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Univ of Cincinnati
  • Univ of Pennsylvania at Philadelphia
  • Julio Arroyo
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 28, 2000
Last Updated
July 31, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00005572
Brief Title
A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection
Official Title
Study of Pathogen-Specific Immune Responses and General Immune Competence in Opportunistic Infections
Study Type
Observational

2. Study Status

Record Verification Date
June 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
90 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron D'Amico
Organizational Affiliation
Beth Israel Med Ctr
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Southern California / LA County USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Marin County Specialty Clinic
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Methodist Hosp of Indiana / Life Care Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Univ of Pennsylvania at Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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