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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 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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. 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 Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Participants oftentimes recieve the finest healthcare available for their 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 condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

Home > "A" Clinical Trials Conditions > 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

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



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

For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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. Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 700

Location and Contact Information:

Overall Study Official:
El-SadrW,  Study Chair, 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Beth Israel Deaconess Med Ctr
Boston,  Massachusetts,  02215
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Olive View Med Ctr
Sylmar,  California,  91342
United States
 

Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta,  Georgia,  303652225
United States
 

Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick,  New Jersey,  08903
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

Adirondack Med Ctr at Saranac Lake
Albany,  New York,  122083479
United States
 

Whitman - Walker Clinic / Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  200072197
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

SUNY / Health Sciences Ctr at Brooklyn
Brooklyn,  New York,  112032098
United States
 

Vanderbilt Univ Med Ctr
Nashville,  Tennessee,  37203
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville,  Tennessee,  37920
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

Louisiana Community AIDS Research Program
New Orleans,  Louisiana,  70112
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Summitt Med Ctr / San Francisco Gen Hosp
Oakland,  California,  94609
United States
 

Great Lakes Hemophilia Foundation
Wauwatosa,  Wisconsin,  532130127
United States
 

Albany Med College / Division of HIV Medicine A158
Albany,  New York,  122083479
United States
 

Highland Gen Hosp / San Francisco Gen Hosp
Oakland,  California,  946021018
United States
 

Yale Univ / New Haven
New Haven,  Connecticut,  065102483
United States
 

Community Consortium of San Francisco
San Francisco,  California,  94110
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Dr John Dunkel
Huntsville,  Alabama,  35801
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

HIV Ctr - District of Columbia Gen Hosp
Washington D.C.,  District of Columbia,  200072197
United States
 

Montefiore Med Ctr / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore,  Maryland,  212052196
United States
 

Stanford Univ Med Ctr
Stanford,  California,  943055107
United States
 

Denver Dept of Health and Hosps
Denver,  Colorado,  80262
United States
 

Denver CPCRA / Denver Public Hlth
Denver,  Colorado,  802044507
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Thomas Jefferson Univ Hosp
Philadelphia,  Pennsylvania,  191075098
United States
 

Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

Univ of Minnesota
Minneapolis,  Minnesota,  55455
United States
 

Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  20007
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

SUNY / State Univ of New York
Syracuse,  New York,  13210
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Comprehensive AIDS Alliance of Detroit
Detroit,  Michigan,  48201
United States
 

Univ of Iowa Hosp and Clinic
Iowa City,  Iowa,  52242
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  100323784
United States
 

Moses H Cone Memorial Hosp
Greensboro,  North Carolina,  27401
United States
 

Queens Med Ctr
Honolulu,  Hawaii,  96816
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Saint Clare's Hosp and Health Ctr
New York City,  New York,  10019
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Children's Hosp of Los Angeles
Los Angeles,  California,  90027
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Univ of Southern California / LA County USC Med Ctr
Los Angeles,  California,  900331079
United States
 

Rose Med Ctr
Denver,  Colorado,  80262
United States
 

Univ of Nebraska Med Ctr
Omaha,  Nebraska,  681985130
United States
 

Bronx Veterans Administration / Mount Sinai Hosp
Bronx,  New York,  10468
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

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

AIDS Research Alliance - Chicago
Chicago,  Illinois,  60657
United States
 

USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr
Los Angeles,  California,  900334508
United States
 

Boston Med Ctr
Boston,  Massachusetts,  02118
United States
 

San Mateo AIDS Program / Stanford Univ
Stanford,  California,  943055107
United States
 

Carolinas Med Ctr
Charlotte,  North Carolina,  28203
United States
 

Wake County Dept of Health
Raleigh,  North Carolina,  27610
United States
 

Univ of California / San Diego Treatment Ctr
San Diego,  California,  921036325
United States
 

Mid - Hudson Care Ctr
Albany,  New York,  122083479
United States
 

Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester,  Massachusetts,  01605
United States
 

Hennepin County Med Clinic
Minneapolis,  Minnesota,  55415
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C.,  District of Columbia,  20422
United States
 

Med Univ of South Carolina / UNC
Charleston,  South Carolina,  29425
United States
 

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose,  California,  951282699
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

Univ of Texas Galveston
Galveston,  Texas,  775550435
United States
 

Harbor UCLA Med Ctr
Torrance,  California,  90502
United States
 

North Jersey Community Research Initiative
Newark,  New Jersey,  071032842
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Kaiser Permanente Franklin Med Ctr
Denver,  Colorado,  80262
United States
 

Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland,  Oregon,  972109951
United States
 

St Paul Ramsey Med Ctr
St. Paul,  Minnesota,  55101
United States
 

Henry Ford Hosp
Detroit,  Michigan,  48202
United States
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 


Additional Information:
Study ID Numbers:
  ACTG 277;  CPCRA 034
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000802

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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

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