NCT00002030

Brief Summary

To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of aerosol pentamidine when used as a prophylactic agent in patients who have had at least two or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Pneumonia, Pneumocystis CariniiHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsPneumonia, Pneumocystis cariniiPentamidineAerosolsAcquired Immunodeficiency Syndrome

Interventions

Pentamidine isethionateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT).
  • Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study.
  • Concurrent Treatment:
  • Allowed:
  • Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study.
  • Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP).
  • Patients must be free of acute medical problems.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT).

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Requiring ongoing active therapy for an opportunistic infection at the time of study entry.
  • Toxoplasmosis.
  • Cryptococcus.
  • Pulmonary Kaposi's sarcoma (KS).
  • Asthma poorly controlled by medication.
  • Concurrent Medication:
  • Excluded:
  • Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
  • Septra, Fansidar, Dapsone, or eflornithine).
  • Concurrent Treatment:
  • Excluded:
  • Transfusion dependency defined as \> 1 blood transfusion per month.
  • Patients with the following are excluded:
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisons Corp

Rochester, New York, 14603, United States

Location

MeSH Terms

Conditions

Pneumonia, PneumocystisHIV InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

BenzamidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1989-11

Locations

US(1)