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

Summary

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

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

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

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.

Locations and Contacts

Community Consortium of San Francisco, San Francisco, California 94110, United States

Denver CPCRA / Denver Public Hlth, Denver, Colorado 802044507, United States

Wilmington Hosp / Med Ctr of Delaware, Wilmington, Delaware 19899, United States

Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia 20422, United States

AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States

Wishard Hosp / Indiana Univ Hosp, Indianapolis, Indiana 46202, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana 70112, United States

Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

North Jersey Community Research Initiative, Newark, New Jersey 071032842, United States

Bronx Lebanon Hosp Ctr, Bronx, New York 10456, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 972109951, United States

Richmond AIDS Consortium, Richmond, Virginia 23298, United States

Additional Information

Click here for more information about Pentamidine isethionate

Related 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)


Last updated: March 28, 2012

Page last updated: August 23, 2015

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