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
- Conditions
- Pneumonia, Pneumocystis CariniiHIV Infections
- Registration Number
- NCT00000908
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
Kaiser Permanente LAMC
🇺🇸Los Angeles, California, United States
Marin County Specialty Clinic
🇺🇸San Rafael, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸St. Louis, Missouri, 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
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Univ of Hawaii / Leahi Hosp
🇺🇸Honolulu, Hawaii, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Louis A Weiss Memorial Hosp
🇺🇸Chicago, Illinois, 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
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Howard Univ
🇺🇸Washington, District of Columbia, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Kaiser Foundation Hosp
🇺🇸Harbor City, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
🇺🇸San Jose, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
🇺🇸Rochester, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Kentucky Lexington
🇺🇸Cincinnati, Ohio, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Chelsea Ctr
🇺🇸New York, New York, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States