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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Pneumonia, Pneumocystis Carinii
• Intervention / Treatment: Drug: Dapsone; Drug: Pentamidine isethionate

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.

• Study Type: Interventional
• Enrollment: 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Community Consortium of San Francisco
  • Colorado
    • Denver, Colorado, United States, 802044507
      • Denver CPCRA / Denver Public Hlth
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • Wilmington Hosp / Med Ctr of Delaware
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Veterans Administration Med Ctr / Regional AIDS Program
  • Illinois
    • Chicago, Illinois, United States, 60657
      • AIDS Research Alliance - Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard Hosp / Indiana Univ Hosp
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hosp
    • Detroit, Michigan, United States, 48201
      • Comprehensive AIDS Alliance of Detroit
  • New Jersey
    • Newark, New Jersey, United States, 071032842
      • North Jersey Community Research Initiative
  • New York
    • Bronx, New York, United States, 10456
      • Bronx Lebanon Hosp Ctr
    • New York, New York, United States, 10037
      • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Oregon
    • Portland, Oregon, United States, 972109951
      • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Richmond AIDS Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Jacobus Pharmaceutical; Fujisawa Pharmaceutical Co

Publications and helpful links

General 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)

Study record dates

Study Major Dates

• Study Completion (Actual): June 1, 1994

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Pneumonia, Pneumocystis carinii; Dapsone; Pentamidine
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Lung Diseases, Fungal; Pneumocystis Infections; Pneumonia; Pneumonia, Pneumocystis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Trypanocidal Agents; Dapsone; Pentamidine
• Other Study ID Numbers: CPCRA 013; 11565 (Registry Identifier: DAIDS ES Registry Number)