A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection
Study of Pathogen-Specific Immune Responses and General Immune Competence in Opportunistic Infections
2 other identifiers
observational
90
1 country
16
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 4, 2008
June 1, 2003
April 28, 2000
July 31, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
- +20 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Marin County Specialty Clinic
San Rafael, California, 94903, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ron D'Amico
Beth Israel Med Ctr
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 28, 2000
First Posted
August 31, 2001
Last Updated
August 4, 2008
Record last verified: 2003-06