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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000908
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2003
  Purpose

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.


Condition
Pneumonia, Pneumocystis Carinii
HIV Infections

Study Type: Observational
Study Design: Observational Model: Natural History
Official Title: Impact of Discontinuing PCP Prophylaxis in Subjects Receiving Antiretroviral Therapies Who Have Had Increases in CD4 Counts to > 200 Cells/mm3

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 250
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000908

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Kaiser Foundation Hosp
Harbor City, California, United States, 90710
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Kaiser Permanente LAMC
Los Angeles, California, United States, 90027
Willow Clinic
Menlo Park, California, United States, 94025
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Marin County Specialty Clinic
San Rafael, California, United States, 94903
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
Howard Univ
Washington, District of Columbia, United States, 20059
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Hawaii
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60612
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, United States, 63112
United States, Nebraska
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
United States, New York
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Mount Sinai Med Ctr
New York, New York, United States, 10029
Cornell Univ Med Ctr
New York, New York, United States, 10021
Beth Israel Med Ctr
New York, New York, United States, 10003
Chelsea Ctr
New York, New York, United States, 10021
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, United States, 14642
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Univ of Kentucky Lexington
Cincinnati, Ohio, United States, 45267
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Investigators
Study Chair: Susan Koletar
Study Chair: Alison Heald
Study Chair: Robert Murphy
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000908     History of Changes
Other Study ID Numbers: ACTG 888
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Antiviral Agents
CD4 Lymphocyte Count
RNA, Viral

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections

ClinicalTrials.gov processed this record on August 21, 2014