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
NCT ID: NCT00000908
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NATURAL_HISTORY
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Susan Koletar
Role: STUDY_CHAIR
Alison Heald
Role: STUDY_CHAIR
Robert Murphy
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Kaiser Foundation Hosp
Harbor City, California, United States
Kaiser Permanente LAMC
Los Angeles, California, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Willow Clinic
Menlo Park, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States
Marin County Specialty Clinic
San Rafael, California, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States
Stanford Univ Med Ctr
Stanford, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Howard Univ
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Emory Univ
Atlanta, Georgia, United States
Queens Med Ctr
Honolulu, Hawaii, United States
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States
Boston Med Ctr
Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Chelsea Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
MetroHealth Med Ctr
Cleveland, Ohio, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Washington
Seattle, Washington, United States
Univ of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Koletar SL, Heald AE, Finkelstein D, Hafner R, Currier JS, McCutchan JA, Vallee M, Torriani FJ, Powderly WG, Fass RJ, Murphy RL; ACTG 888 Study Team. A prospective study of discontinuing primary and secondary Pneumocystis carinii pneumonia prophylaxis after CD4 cell count increase to > 200 x 106 /l. AIDS. 2001 Aug 17;15(12):1509-15. doi: 10.1097/00002030-200108170-00008.
Other Identifiers
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ACTG 888
Identifier Type: -
Identifier Source: org_study_id