Pneumonia, Pneumocystis CariniiNCT00000908
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
An observational study of Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 54 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- How many people
- 250 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States53 sites
Emory Univ
Atlanta, Georgia, 30308
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Boston Med Ctr
Boston, Massachusetts, 02118
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr
Durham, North Carolina, 27710
Kaiser Foundation Hosp
Harbor City, California, 90710
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Kaiser Permanente LAMC
Los Angeles, California, 90027
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Willow Clinic
Menlo Park, California, 94025
Univ of Miami School of Medicine
Miami, Florida, 331361013
Univ of Minnesota
Minneapolis, Minnesota, 55455
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Chelsea Ctr
New York, New York, 10021
Cornell Univ Med Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
San Francisco Gen Hosp
San Francisco, California, 941102859
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
Marin County Specialty Clinic
San Rafael, California, 94903
Univ of Washington
Seattle, Washington, 98104
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
Stanford Univ Med Ctr
Stanford, California, 943055107
Howard Univ
Washington D.C., District of Columbia, 20059
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Antiviral Agents, CD4 Lymphocyte Count, RNA, Viral
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, AIDS-Related Opportunistic Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Pneumocystis CariniiStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Enrolment
- 250 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan Koletar, Study chairAlison Heald, Study chairRobert Murphy, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000908
- Sponsor's protocol ID
- ACTG 888
- Status last verified
- Feb 2003
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 11504983
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Discontinuing PCP Prophylaxis in Subjects Receiving Antiretroviral Therapies Who Have Had Increases in CD4 Counts to > 200 Cells/mm3
- ClinicalTrials.gov ID
- NCT00000908
- Acronym / sponsor ID
- ACTG 888
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Antiviral Agents, CD4 Lymphocyte Count, RNA, Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Natural history
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 11504983Koletar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Koletar study chair
Alison Heald study chair
Robert Murphy study chair
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 54 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.