A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
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| ClinicalTrials.gov Identifier: NCT00001028 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : March 29, 2012
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia, Pneumocystis Carinii HIV Infections | Drug: Pentamidine isethionate Drug: Dapsone | Phase 3 |
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 (Clinical Trial) |
| Enrollment : | 400 participants |
| 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 |
| Actual Study Completion Date : | June 1994 |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001028
| 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 | |
| Study Chair: | El-Sadr W | ||
| Study Chair: | Luskin-Hawk R |
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001028 History of Changes |
| Other Study ID Numbers: |
CPCRA 013 11565 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | March 29, 2012 |
| Last Verified: | March 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Pneumonia, Pneumocystis carinii Pentamidine Dapsone Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
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HIV Infections Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal |
Mycoses Pneumocystis Infections Trimethoprim Dapsone Pentamidine Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2C8 Inhibitors |