Completed

Age: 13Years +
All Genders
ID00000908

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2005-06-24

250

Participants Needed

54

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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).
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 54 locations

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Status Unknown

2

Kaiser Foundation Hosp

Harbor City, California, United States, 90710

Status Unknown

3

Kaiser Permanente LAMC

Los Angeles, California, United States, 90027

Status Unknown

4

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States, 900331079

Status Unknown

5

Willow Clinic

Menlo Park, California, United States, 94025

Status Unknown

6

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

Status Unknown

7

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States, 941102859

Status Unknown

8

San Francisco Gen Hosp

San Francisco, California, United States, 941102859

Status Unknown

9

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States, 951282699

Status Unknown

10

Marin County Specialty Clinic

San Rafael, California, United States, 94903

Status Unknown

11

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States, 943055107

Status Unknown

12

Stanford Univ Med Ctr

Stanford, California, United States, 943055107

Status Unknown

13

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States, 80262

Status Unknown

14

Howard Univ

Washington D.C., District of Columbia, United States, 20059

Status Unknown

15

Univ of Miami School of Medicine

Miami, Florida, United States, 331361013

Status Unknown

16

Emory Univ

Atlanta, Georgia, United States, 30308

Status Unknown

17

Queens Med Ctr

Honolulu, Hawaii, United States, 96816

Status Unknown

18

Univ of Hawaii / Leahi Hosp

Honolulu, Hawaii, United States, 96816

Status Unknown

19

Northwestern Univ Med School

Chicago, Illinois, United States, 60611

Status Unknown

20

Cook County Hosp

Chicago, Illinois, United States, 60612

Status Unknown

21

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States, 60612

Status Unknown

22

Louis A Weiss Memorial Hosp

Chicago, Illinois, United States, 60640

Status Unknown

23

Indiana Univ Hosp

Indianapolis, Indiana, United States, 462025250

Status Unknown

24

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States, 46202

Status Unknown

25

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, United States, 46202

Status Unknown

26

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21287

Status Unknown

27

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States, 02114

Status Unknown

28

Boston Med Ctr

Boston, Massachusetts, United States, 02118

Status Unknown

29

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States, 02215

Status Unknown

30

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States, 02215

Status Unknown

31

Univ of Minnesota

Minneapolis, Minnesota, United States, 55455

Status Unknown

32

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States, 63112

Status Unknown

33

Univ of Nebraska Med Ctr

Omaha, Nebraska, United States, 681985130

Status Unknown

34

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States, 14215

Status Unknown

35

Beth Israel Med Ctr

New York, New York, United States, 10003

Status Unknown

36

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016

Status Unknown

37

Chelsea Ctr

New York, New York, United States, 10021

Status Unknown

38

Cornell Univ Med Ctr

New York, New York, United States, 10021

Status Unknown

39

Mount Sinai Med Ctr

New York, New York, United States, 10029

Status Unknown

40

St Mary's Hosp (Univ of Rochester/Infectious Diseases)

Rochester, New York, United States, 14642

Status Unknown

41

Univ of Rochester Medical Center

Rochester, New York, United States, 14642

Status Unknown

42

Univ of North Carolina

Chapel Hill, North Carolina, United States, 275997215

Status Unknown

43

Duke Univ Med Ctr

Durham, North Carolina, United States, 27710

Status Unknown

44

Univ of Cincinnati

Cincinnati, Ohio, United States, 452670405

Status Unknown

45

Univ of Kentucky Lexington

Cincinnati, Ohio, United States, 45267

Status Unknown

46

Case Western Reserve Univ

Cleveland, Ohio, United States, 44106

Status Unknown

47

MetroHealth Med Ctr

Cleveland, Ohio, United States, 441091998

Status Unknown

48

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States, 432101228

Status Unknown

49

Philadelphia Veterans Administration Med Ctr

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

50

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

51

Univ of Pittsburgh Med Ctr

Pittsburgh, Pennsylvania, United States, 15213

Status Unknown

52

Julio Arroyo

West Columbia, South Carolina, United States, 29169

Status Unknown

53

Univ of Washington

Seattle, Washington, United States, 98104

Status Unknown

54

Univ of Puerto Rico

San Juan, Puerto Rico, 009365067

Status Unknown

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

A prospective study of discontinuing primary and secondary Pneumocystis carinii pneumonia prophylaxis after CD4 cell count increase to > 200 x 106 /l.

S L Koletar, A E Heald, D Finkelstein...

https://pubmed.ncbi.nlm.nih.gov/11504983