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 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000908 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Impact of Discontinuing PCP Prophylaxis in Subjects Receiving Antiretroviral Therapies Who Have Had Increases in CD4 Counts to > 200 Cells/mm3

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History

Condition ^ICMJE

Pneumonia, Pneumocystis Carinii
HIV Infections

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

Koletar SL, Heald AE, Finkelstein D, Hafner R, Currier JS, McCutchan JA, Vallee M, Torriani FJ, Powderly WG, Fass RJ, Murphy RL. 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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00000908

Responsible Party

Study ID Numbers ^ICMJE

ACTG 888

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Susan Koletar
Study Chair:	Alison Heald
Study Chair:	Robert Murphy

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

February 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP