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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000908

Collaborator

(none)

250

Enrollment

Locations

4.6

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii HIV Infections

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

Study Type:

Observational

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Kaiser Foundation Hosp	Harbor City	California	United States	90710
3	Kaiser Permanente LAMC	Los Angeles	California	United States	90027
4	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California	United States	900331079
5	Willow Clinic	Menlo Park	California	United States	94025
6	Univ of California / San Diego Treatment Ctr	San Diego	California	United States	921036325
7	San Francisco AIDS Clinic / San Francisco Gen Hosp	San Francisco	California	United States	941102859
8	San Francisco Gen Hosp	San Francisco	California	United States	941102859
9	Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium	San Jose	California	United States	951282699
10	Marin County Specialty Clinic	San Rafael	California	United States	94903
11	San Mateo AIDS Program / Stanford Univ	Stanford	California	United States	943055107
12	Stanford Univ Med Ctr	Stanford	California	United States	943055107
13	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
14	Howard Univ	Washington	District of Columbia	United States	20059
15	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
16	Emory Univ	Atlanta	Georgia	United States	30308
17	Queens Med Ctr	Honolulu	Hawaii	United States	96816
18	Univ of Hawaii / Leahi Hosp	Honolulu	Hawaii	United States	96816
19	Northwestern Univ Med School	Chicago	Illinois	United States	60611
20	Cook County Hosp	Chicago	Illinois	United States	60612
21	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
22	Louis A Weiss Memorial Hosp	Chicago	Illinois	United States	60640
23	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
24	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana	United States	46202
25	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana	United States	46202
26	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
27	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts	United States	02114
28	Boston Med Ctr	Boston	Massachusetts	United States	02118
29	Beth Israel Deaconess - West Campus	Boston	Massachusetts	United States	02215
30	Beth Israel Deaconess Med Ctr	Boston	Massachusetts	United States	02215
31	Univ of Minnesota	Minneapolis	Minnesota	United States	55455
32	St Louis Regional Hosp / St Louis Regional Med Ctr	St. Louis	Missouri	United States	63112
33	Univ of Nebraska Med Ctr	Omaha	Nebraska	United States	681985130
34	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
35	Beth Israel Med Ctr	New York	New York	United States	10003
36	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
37	Chelsea Ctr	New York	New York	United States	10021
38	Cornell Univ Med Ctr	New York	New York	United States	10021
39	Mount Sinai Med Ctr	New York	New York	United States	10029
40	St Mary's Hosp (Univ of Rochester/Infectious Diseases)	Rochester	New York	United States	14642
41	Univ of Rochester Medical Center	Rochester	New York	United States	14642
42	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
43	Duke Univ Med Ctr	Durham	North Carolina	United States	27710
44	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
45	Univ of Kentucky Lexington	Cincinnati	Ohio	United States	45267
46	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
47	MetroHealth Med Ctr	Cleveland	Ohio	United States	441091998
48	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	432101228
49	Philadelphia Veterans Administration Med Ctr	Philadelphia	Pennsylvania	United States	19104
50	Univ of Pennsylvania at Philadelphia	Philadelphia	Pennsylvania	United States	19104
51	Univ of Pittsburgh Med Ctr	Pittsburgh	Pennsylvania	United States	15213
52	Julio Arroyo	West Columbia	South Carolina	United States	29169
53	Univ of Washington	Seattle	Washington	United States	98104
54	Univ of Puerto Rico	San Juan		Puerto Rico	009365067