A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00000802

Collaborator

(none)

700

Enrollment

Locations

15.9

Patients Per Site

Study Details

Study Description

Brief Summary

To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides.

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Atovaquone Drug: Dapsone	Phase 3

Detailed Description

Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

Actual Study Completion Date :

Jul 1, 1997

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

Concurrent Medication: Strongly recommended:

Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count < 100 cells/mm3 and are toxoplasmosis seropositive.

Patients must have:

Working diagnosis of HIV infection.
CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocyte count at any time in the past OR a history of PCP.
History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation.

NOTE:

Pregnant patients are eligible at the clinician's discretion.

Prior Medication:

Allowed:

Prior PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active pneumocystosis.

Concurrent Medication:

Excluded:

PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity.

Patients with the following prior conditions are excluded:

Known treatment-limiting reaction to dapsone or atovaquone.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Therapeutics CRS	Birmingham	Alabama	United States	35294
2	USC CRS	Los Angeles	California	United States	900331079
3	Stanford CRS	Palo Alto	California	United States	943055107
4	Ucsd, Avrc Crs	San Diego	California	United States	921036325
5	Ucsf Aids Crs	San Francisco	California	United States	941102859
6	Santa Clara Valley Med. Ctr.	San Jose	California	United States	951282699
7	San Mateo County AIDS Program	San Mateo	California	United States
8	Harbor-UCLA Med. Ctr. CRS	Torrance	California	United States	90502
9	University of Colorado Hospital CRS	Aurora	Colorado	United States	80262
10	Howard University Hosp., Div. of Infectious Diseases, ACTU	Washington	District of Columbia	United States	20059
11	Univ. of Miami AIDS CRS	Miami	Florida	United States	331361013
12	Emory Univ. Hemophilia Program Office	Atlanta	Georgia	United States	303652225
13	Queens Med. Ctr.	Honolulu	Hawaii	United States	96816
14	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii	United States	96816
15	Northwestern University CRS	Chicago	Illinois	United States	60611
16	Cook County Hosp. CORE Ctr.	Chicago	Illinois	United States	60612
17	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois	United States	60612
18	Weiss Memorial Hosp.	Chicago	Illinois	United States	60640
19	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana	United States	462025250
20	Univ. of Iowa Healthcare, Div. of Infectious Diseases	Iowa City	Iowa	United States	52242
21	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland	United States	21287
22	Bmc Actg Crs	Boston	Massachusetts	United States	02118
23	Beth Israel Deaconess - East Campus A0102 CRS	Boston	Massachusetts	United States	02215
24	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts	United States
25	Hennepin County Med. Ctr., Div. of Infectious Diseases	Minneapolis	Minnesota	United States	55415
26	University of Minnesota, ACTU	Minneapolis	Minnesota	United States	55455
27	St. Louis ConnectCare, Infectious Diseases Clinic	Saint Louis	Missouri	United States
28	Washington U CRS	Saint Louis	Missouri	United States
29	Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.	Omaha	Nebraska	United States
30	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York	United States	13210
31	Beth Israel Med. Ctr. (Mt. Sinai)	New York	New York	United States
32	NY Univ. HIV/AIDS CRS	New York	New York	United States
33	Univ. of Rochester ACTG CRS	Rochester	New York	United States	14642
34	Unc Aids Crs	Chapel Hill	North Carolina	United States
35	Carolinas HealthCare System, Carolinas Med. Ctr.	Charlotte	North Carolina	United States	28203
36	Regional Center for Infectious Disease, Wendover Medical Center CRS	Greensboro	North Carolina	United States	27401
37	Wake County Health and Human Services CRS	Raleigh	North Carolina	United States	27610
38	Univ. of Cincinnati CRS	Cincinnati	Ohio	United States
39	Case CRS	Cleveland	Ohio	United States	44106
40	MetroHealth CRS	Cleveland	Ohio	United States
41	The Ohio State Univ. AIDS CRS	Columbus	Ohio	United States	432101228
42	Hosp. of the Univ. of Pennsylvania CRS	Philadelphia	Pennsylvania	United States	19104
43	University of Washington AIDS CRS	Seattle	Washington	United States	981224304
44	Mbeya Med. Research Program, Mbeya Referral Hosp. CRS	Mbeya		Tanzania