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| ID | Type | Description | Link |
|---|---|---|---|
| CPCRA 034 | |||
| 11253 | Registry Identifier | DAIDS-ES |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atovaquone | Drug | |||
| Dapsone | Drug |
Inclusion Criteria
Concurrent Medication: Strongly recommended:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
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| Name | Affiliation | Role |
|---|---|---|
| El-Sadr W | Study Chair | |
| Luskin-Hawk R | Study Chair | |
| Murphy R | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294 | United States | ||
| USC CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9862944 | Background | El-Sadr WM, Murphy RL, Yurik TM, Luskin-Hawk R, Cheung TW, Balfour HH Jr, Eng R, Hooton TM, Kerkering TM, Schutz M, van der Horst C, Hafner R. Atovaquone compared with dapsone for the prevention of Pneumocystis carinii pneumonia in patients with HIV infection who cannot tolerate trimethoprim, sulfonamides, or both. Community Program for Clinical Research on AIDS and the AIDS Clinical Trials Group. N Engl J Med. 1998 Dec 24;339(26):1889-95. doi: 10.1056/NEJM199812243392604. | |
| Background | Caldwell P, Murphy R, Chan C, Yurik T, Scott J, el-Sadr W. Atovaquone suspension (ATQ) for prophylaxis of Pneumocystis carinii pneumonia (PCP): effects of baseline prophylaxis on safety and efficacy. Int Conf AIDS. 1998;12:297 (abstract no 22178) | ||
| Background | Murphy R, El-Sadr W, Cheung T, Luskin-Hawk R, Yurik T, Neaton J, Hafner R. Impact of protease inhibitor containing regimens on the risk of developing opportunistic infections and mortality in the CPCRA 034/ACTG 277 study. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:113 (abstract no 181) |
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| Los Angeles |
| California |
| 900331079 |
| United States |
| Stanford CRS | Palo Alto | California | 943055107 | United States |
| Ucsd, Avrc Crs | San Diego | California | 921036325 | United States |
| Ucsf Aids Crs | San Francisco | California | 941102859 | United States |
| Santa Clara Valley Med. Ctr. | San Jose | California | 951282699 | United States |
| San Mateo County AIDS Program | San Mateo | California | United States |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | United States |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | United States |
| Howard University Hosp., Div. of Infectious Diseases, ACTU | Washington D.C. | District of Columbia | 20059 | United States |
| Univ. of Miami AIDS CRS | Miami | Florida | 331361013 | United States |
| Emory Univ. Hemophilia Program Office | Atlanta | Georgia | 303652225 | United States |
| Queens Med. Ctr. | Honolulu | Hawaii | 96816 | United States |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | United States |
| Northwestern University CRS | Chicago | Illinois | 60611 | United States |
| Cook County Hosp. CORE Ctr. | Chicago | Illinois | 60612 | United States |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | 60612 | United States |
| Weiss Memorial Hosp. | Chicago | Illinois | 60640 | United States |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 462025250 | United States |
| Univ. of Iowa Healthcare, Div. of Infectious Diseases | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | United States |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess - East Campus A0102 CRS | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital ACTG CRS | Boston | Massachusetts | United States |
| Hennepin County Med. Ctr., Div. of Infectious Diseases | Minneapolis | Minnesota | 55415 | United States |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | United States |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | United States |
| Washington U CRS | St Louis | Missouri | United States |
| Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha | Nebraska | United States |
| SUNY - Buffalo, Erie County Medical Ctr. | Buffalo | New York | 13210 | United States |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | United States |
| Unc Aids Crs | Chapel Hill | North Carolina | United States |
| Carolinas HealthCare System, Carolinas Med. Ctr. | Charlotte | North Carolina | 28203 | United States |
| Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro | North Carolina | 27401 | United States |
| Wake County Health and Human Services CRS | Raleigh | North Carolina | 27610 | United States |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | United States |
| Case CRS | Cleveland | Ohio | 44106 | United States |
| MetroHealth CRS | Cleveland | Ohio | United States |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 432101228 | United States |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 981224304 | United States |
| Mbeya Med. Research Program, Mbeya Referral Hosp. CRS | Mbeya | Tanzania |
| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016720 | Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D053626 | Atovaquone |
| D003622 | Dapsone |
| ID | Term |
|---|---|
| D009285 | Naphthoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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