A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides

This study has been completed.
Sponsor:
Collaborators:
Jacobus Pharmaceutical
Fujisawa Pharmaceutical Co
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001028
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

To compare the safety and efficacy of aerosolized pentamidine and dapsone in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients who are intolerant to trimethoprim and/or sulfonamides.

Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause side effects. This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole.


Condition Intervention Phase
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Pentamidine isethionate
Drug: Dapsone
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Randomized, Comparative, Prospective Study of Monthly Aerosolized Pentamidine and Thrice Weekly Dapsone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant to Trimethoprim and/or Sulfonamides

Resource links provided by NLM:


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

Estimated Enrollment: 400
Study Completion Date: June 1994
Detailed Description:

Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause side effects. This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole.

Patients are evenly divided between two treatment arms to receive either aerosolized pentamidine every 4 weeks or dapsone orally three times weekly. Follow-up data is collected every 3 months, and patients are clinically evaluated every 6 months. Patients who develop PCP or a severe or persistent study drug toxicity may be switched to the alternative study drug at the clinician's discretion. Average duration of follow-up is 2 years.

  Eligibility

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

Inclusion Criteria

Patients must have:

  • HIV infection.
  • CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocytes OR a history of prior PCP.
  • History of intolerance to trimethoprim and/or sulfonamides.
  • No active pneumocystosis. Patient or guardian must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Any medication with potential anti-PCP activity.

Patients with the following prior conditions are excluded:

  • Treatment-limiting reaction to pentamidine or dapsone.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001028

Locations
United States, California
Community Consortium of San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
United States, Delaware
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program
Washington, District of Columbia, United States, 20422
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
United States, Indiana
Wishard Hosp / Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
United States, Michigan
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, New Jersey
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10456
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 972109951
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Jacobus Pharmaceutical
Fujisawa Pharmaceutical Co
Investigators
Study Chair: El-Sadr W
Study Chair: Luskin-Hawk R
  More Information

Additional Information:
Publications:
el-Sadr W, Wentworth D, Dehlinger M, Larntz K. Design and implementation of a community-based trial for prophylaxis for P. carinii pneumonia (PCP). Int Conf AIDS. 1993 Jun 6-11;9(1):79 (abstract no WS-B36-2)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001028     History of Changes
Other Study ID Numbers: CPCRA 013, 11565
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pneumonia, Pneumocystis carinii
Pentamidine
Dapsone
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Pneumonia
Pneumonia, Pneumocystis
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lung Diseases
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Dapsone
Pentamidine
Trimethoprim
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014