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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

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   AIDS    Pneumonia   

Drug Information available for:   Trimethoprim    Dapsone    Atovaquone    Clotrimazole    Miconazole    Miconazole nitrate    Tioconazole   

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   700

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
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000802

Show 89 study locations  Show 89 Study Locations

Sponsors and Collaborators

Investigators
Study Chair:     El-Sadr W    
Study Chair:     Luskin-Hawk R    
Study Chair:     Murphy R    
  More Information


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)
 

Study ID Numbers:   ACTG 277, CPCRA 034
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000802
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pneumonia, Pneumocystis carinii  
Dapsone  
Antifungal Agents  
Acquired Immunodeficiency Syndrome  
atovaquone  

Study placed in the following topic categories:
Trimethoprim
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Atovaquone
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Dapsone
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Infection
Folic Acid Antagonists
Pharmacologic Actions
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Lentivirus Infections
Leprostatic Agents

ClinicalTrials.gov processed this record on October 31, 2008




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