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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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Atovaquone (Drug); Dapsone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
El-Sadr W, Study Chair
Luskin-Hawk R, Study Chair
Murphy R, Study Chair

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Detailed description: 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

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS, Mbeya, Tanzania

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, 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

Cook County Hosp. CORE Ctr., Chicago, Illinois 60612, United States

Northwestern University CRS, Chicago, Illinois 60611, 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

Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts 02215, United States

Bmc Actg Crs, Boston, Massachusetts 02118, 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

Additional Information

Related publications:

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.

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)

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)


Last updated: April 2, 2012

Page last updated: August 23, 2015

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