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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000802 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Atovaquone Drug: Dapsone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 700 |
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| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Dr John Dunkel | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Children's Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Community Consortium of San Francisco | |
| San Francisco, California, United States, 94110 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
| San Jose, California, United States, 951282699 | |
| Highland Gen Hosp / San Francisco Gen Hosp | |
| Oakland, California, United States, 946021018 | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr | |
| Los Angeles, California, United States, 900334508 | |
| United States, Colorado | |
| Denver CPCRA / Denver Public Hlth | |
| Denver, Colorado, United States, 802044507 | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| Denver Dept of Health and Hosps | |
| Denver, Colorado, United States, 80262 | |
| Kaiser Permanente Franklin Med Ctr | |
| Denver, Colorado, United States, 80262 | |
| Rose Med Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr / Regional AIDS Program | |
| Washington, District of Columbia, United States, 20422 | |
| Howard Univ | |
| Washington, District of Columbia, United States, 20059 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Whitman - Walker Clinic / Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 200072197 | |
| HIV Ctr - District of Columbia Gen Hosp | |
| Washington, District of Columbia, United States, 200072197 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr | |
| Atlanta, Georgia, United States, 303652225 | |
| United States, Hawaii | |
| Queens Med Ctr | |
| Honolulu, Hawaii, United States, 96816 | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Louis A Weiss Memorial Hosp | |
| Chicago, Illinois, United States, 60640 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Iowa | |
| Univ of Iowa Hosp and Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Louisiana Community AIDS Research Program | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| State of MD Div of Corrections / Johns Hopkins Univ Hosp | |
| Baltimore, Maryland, United States, 212052196 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Comprehensive AIDS Alliance of Detroit | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| St Paul Ramsey Med Ctr | |
| St. Paul, Minnesota, United States, 55101 | |
| Hennepin County Med Clinic | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | |
| St. Louis, Missouri, United States, 63112 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New Jersey | |
| Robert Wood Johnson Med School / Hershey Med Ctr | |
| New Brunswick, New Jersey, United States, 08903 | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| United States, New York | |
| SUNY / State Univ of New York | |
| Syracuse, New York, United States, 13210 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 112032098 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Saint Clare's Hosp and Health Ctr | |
| New York, New York, United States, 10019 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 100323784 | |
| Adirondack Med Ctr at Saranac Lake | |
| Albany, New York, United States, 122083479 | |
| Mid - Hudson Care Ctr | |
| Albany, New York, United States, 122083479 | |
| Albany Med College / Division of HIV Medicine A158 | |
| Albany, New York, United States, 122083479 | |
| Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28203 | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Moses H Cone Memorial Hosp | |
| Greensboro, North Carolina, United States, 27401 | |
| Wake County Dept of Health | |
| Raleigh, North Carolina, United States, 27610 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 972109951 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Med Univ of South Carolina / UNC | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | |
| Knoxville, Tennessee, United States, 37920 | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224304 | |
| United States, Wisconsin | |
| Great Lakes Hemophilia Foundation | |
| Wauwatosa, Wisconsin, United States, 532130127 | |
| Study Chair: | El-Sadr W | |
| Study Chair: | Luskin-Hawk R | |
| Study Chair: | Murphy R |
More Information
| Study ID Numbers: | ACTG 277, CPCRA 034 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000802 History of Changes |
| Health Authority: | United States: Federal Government |
|
Pneumonia, Pneumocystis carinii Dapsone Antifungal Agents Acquired Immunodeficiency Syndrome atovaquone |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Trimethoprim Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Renal Agents Infection Anti-Bacterial Agents Pneumonia, Pneumocystis Mycoses Antimalarials Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections |
Therapeutic Uses Dapsone Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Anti-Infective Agents, Urinary Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections Atovaquone |
