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:
National Institute of Allergy and Infectious Diseases (NIAID)
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
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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:
Drug Information available for:
Dapsone
Pentamidine isethionate
Trimethoprim
Trimethoprim hydrochloride
U.S. FDA Resources
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
| Estimated Enrollment: | 400 |
| Study Completion Date: | June 1994 |
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 (Child, Adult, Senior) |
| 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
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
National Institute of Allergy and Infectious Diseases (NIAID)
Jacobus Pharmaceutical
Fujisawa Pharmaceutical Co
Investigators
| Study Chair: | El-Sadr W | |
| Study Chair: | Luskin-Hawk R |
More 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:
|
Pneumonia HIV Infections Pneumonia, Pneumocystis Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lung Diseases, Fungal |
Mycoses Pneumocystis Infections Dapsone Trimethoprim Pentamidine Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents, Urinary |
ClinicalTrials.gov processed this record on September 27, 2016