- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000908
A Study to Evaluate the Impact of Stopping Treatment for the Prevention of Pneumonia in HIV-Positive Patients Receiving Anti-HIV Drugs Who Have Increased CD4 Cell Counts
Impact of Discontinuing PCP Prophylaxis in Subjects Receiving Antiretroviral Therapies Who Have Had Increases in CD4 Counts to > 200 Cells/mm3
The purpose of this study is to see how often Pneumocystis carinii pneumonia (PCP) occurs in HIV-positive patients who have stopped taking medications that help prevent PCP.
The risk of developing PCP may be decreased when an HIV-positive patient's CD4 cell counts (cells of the immune system which fight infection) are more than 200 cells/mm3. This study looks at whether it is acceptable to stop PCP prevention treatment in these patients.
Study Overview
Status
Conditions
Detailed Description
The risk of developing PCP may be decreased with treatment-induced recovery of CD4 counts to > 200 cells/mm3. Few data exist to confirm or negate the continued necessity of PCP prophylaxis for such patients. This study will assess the effects of discontinuing therapy.
Subjects are asked to discontinue PCP prophylaxis if antiretroviral therapy has resulted in a sustained CD4 increase greater than 200 cells/mm3 on two measurements at least 12 weeks apart. They will be evaluated for symptoms and CD4 counts every 8 weeks as well as plasma for HIV-RNA every 16 weeks for 18 months. Subjects whose CD4 count falls to less than 150 cells/mm3 or between 150 and 200 cells/mm3 will have the CD4 count re-evaluated immediately or within 4 weeks. If the second CD4 count is less than 200 cells/mm3 for either case, conventional PCP prophylaxis will be resumed and the subject will be followed on study. Subjects will be followed during study by physical exams and laboratory tests at Weeks 4, 8, and every 8 weeks thereafter.
Study Type
Enrollment
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
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Alabama
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Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham
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California
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Harbor City, California, United States, 90710
- Kaiser Foundation Hosp
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Los Angeles, California, United States, 900331079
- Univ of Southern California / LA County USC Med Ctr
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Los Angeles, California, United States, 90027
- Kaiser Permanente LAMC
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Menlo Park, California, United States, 94025
- Willow Clinic
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San Diego, California, United States, 921036325
- Univ of California / San Diego Treatment Ctr
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San Francisco, California, United States, 941102859
- San Francisco AIDS Clinic / San Francisco Gen Hosp
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San Francisco, California, United States, 941102859
- San Francisco Gen Hosp
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San Jose, California, United States, 951282699
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
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San Rafael, California, United States, 94903
- Marin County Specialty Clinic
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Stanford, California, United States, 943055107
- San Mateo AIDS Program / Stanford Univ
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Stanford, California, United States, 943055107
- Stanford Univ Med Ctr
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Colorado
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Denver, Colorado, United States, 80262
- Univ of Colorado Health Sciences Ctr
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District of Columbia
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Washington, District of Columbia, United States, 20059
- Howard Univ
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Florida
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Miami, Florida, United States, 331361013
- Univ of Miami School of Medicine
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Queens Med Ctr
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Honolulu, Hawaii, United States, 96816
- Univ of Hawaii / Leahi Hosp
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, United States, 60612
- Cook County Hosp
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Chicago, Illinois, United States, 60640
- Louis A Weiss Memorial Hosp
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Indiana
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Indianapolis, Indiana, United States, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, United States, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, United States, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Harvard (Massachusetts Gen Hosp)
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Boston, Massachusetts, United States, 02118
- Boston Med Ctr
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Med Ctr
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Univ of Minnesota
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Missouri
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St. Louis, Missouri, United States, 63112
- St Louis Regional Hosp / St Louis Regional Med Ctr
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Nebraska
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Omaha, Nebraska, United States, 681985130
- Univ of Nebraska Med Ctr
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New York
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Buffalo, New York, United States, 14215
- SUNY / Erie County Med Ctr at Buffalo
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10021
- Cornell Univ Med Ctr
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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New York, New York, United States, 10021
- Chelsea Ctr
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Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
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Rochester, New York, United States, 14642
- St Mary's Hosp (Univ of Rochester/Infectious Diseases)
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North Carolina
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Chapel Hill, North Carolina, United States, 275997215
- Univ of North Carolina
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Durham, North Carolina, United States, 27710
- Duke Univ Med Ctr
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Ohio
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Cincinnati, Ohio, United States, 452670405
- Univ of Cincinnati
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Cincinnati, Ohio, United States, 45267
- Univ of Kentucky Lexington
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Cleveland, Ohio, United States, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, United States, 441091998
- MetroHealth Med Ctr
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Columbus, Ohio, United States, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania at Philadelphia
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia Veterans Administration Med Ctr
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Pittsburgh, Pennsylvania, United States, 15213
- Univ of Pittsburgh Med Ctr
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South Carolina
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West Columbia, South Carolina, United States, 29169
- Julio Arroyo
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Washington
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Seattle, Washington, United States, 98104
- Univ of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Have had 1 CD4 cell count of less than 100 cells/mm3 and have never had PCP, or have had at least 2 CD4 cell counts over 200 cells/mm3 and have had PCP within 6 months prior to study entry.
- Have received PCP prevention medication within 3 months of study entry.
- Are at least 13 years old (need consent if under 18).
- Are taking anti-HIV (antiretroviral) medication at study entry.
Exclusion Criteria
You will not be eligible for this study if you:
- Have active PCP or symptoms of PCP within 2 weeks of study entry.
- Have a fever lasting more than 2 weeks.
- Have oral candidiasis (thrush).
Study Plan
How is the study designed?
Design Details
- Observational Models: Natural History
Collaborators and Investigators
Investigators
- Study Chair: Alison Heald
- Study Chair: Robert Murphy
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG 888
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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