The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before
Launched by FISONS · Aug 30, 2001
Trial Information
Current as of March 23, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Zidovudine (AZT).
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following are excluded:
- * Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
- • Toxoplasmosis.
- • Cryptococcosis.
- • Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
- • Pulmonary Kaposi's sarcoma (KS).
- • Asthma requiring medication.
- • Active therapy for tuberculosis.
- Concurrent Medication:
- Excluded:
- • Active therapy for tuberculosis.
- Patients with the following are excluded:
- * Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
- • Toxoplasmosis.
- • Cryptococcosis.
- • Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
- • Pulmonary Kaposi's sarcoma (KS).
- • Unwilling to sign informed consent.
- • Cannot cooperate with study procedures.
- • Asthma requiring medication.
- Prior Medication:
- Excluded within 30 days of study entry:
- • Antiretrovirals other than zidovudine (AZT).
- • Immunomodulating agents.
- • Corticosteroids.
- Patients must:
- • Have AIDS and recovered from their first episode of cytologically or histologically proven Pneumocystis carinii pneumonia (PCP).
- • Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP.
- • Have positive antibody to HIV by any federally licensed ELISA test kit, or confirmed Western blot test.
- • Have adequate pulmonary function (vital capacity = or \> 80 percent of predicted; forced expiratory volume (FEV), 1 s = or \> 65 percent of total FEV; and corrected pulmonary diffusion capacity \> 60 percent of predicted).
- • Free of acute medical problems.
- • Active substance abuse.
About Fisons
Fisons is a distinguished pharmaceutical company dedicated to advancing healthcare through innovative research and development. With a strong focus on providing effective therapeutic solutions, Fisons specializes in a diverse range of medical fields, including respiratory, oncology, and infectious diseases. Committed to rigorous clinical trials and ethical standards, the company aims to bring safe and effective medications to market, improving patient outcomes and quality of life. Fisons leverages its extensive expertise and collaborative partnerships to drive scientific discovery and ensure compliance with regulatory requirements, positioning itself as a leader in the pharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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