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Search / Trial NCT00002054

A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

Launched by FISONS · Aug 30, 2001

Trial Information

Current as of June 23, 2025

Completed

Keywords

Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Pentamidine Dose Response Relationship, Drug Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients who have completed 16 treatments under Fisons study no. 87-71 entitled, "A Double-Blind Group Comparative Study To Evaluate the Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP." Detailed safety parameters must have been documented for 6 months.
  • Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71.
  • 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 patients with either of the following AIDS-defining O.I.'s at entry:
  • Toxoplasmosis.
  • Cryptococcosis.
  • Pulmonary Kaposi's sarcoma.
  • Asthma poorly controlled by medication.
  • Receiving 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 patients with either of the following AIDS-defining O.I.'s at entry:
  • Toxoplasmosis.
  • Cryptococcosis.
  • Pulmonary Kaposi's sarcoma.
  • Unwilling to sign informed consent.
  • Cannot cooperate with study procedures.
  • Asthma poorly controlled by medication.
  • Receiving active therapy for tuberculosis.
  • 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.

Locations

Rochester, New York, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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