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
3 other identifiers
interventional
700
2 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
July 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
USC CRS
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
Related Publications (3)
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.
PMID: 9862944BACKGROUNDCaldwell 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)
BACKGROUNDMurphy 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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
El-Sadr W
- STUDY CHAIR
Luskin-Hawk R
- STUDY CHAIR
Murphy R