NCT00002292

Brief Summary

To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.

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

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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

August 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 cariniiPentamidineInjections, IntravenousAdministration, InhalationAerosolsAcquired Immunodeficiency Syndrome

Interventions

Pentamidine isethionateDRUG

Eligibility Criteria

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

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Previous history of adverse reaction to pentamidine.
  • History of asthma.
  • Pulmonary Kaposi's sarcoma.
  • Patients with the following are excluded:
  • Previous history of adverse reaction to pentamidine.
  • History of asthma.
  • Pulmonary Kaposi's sarcoma.
  • Inability to understand the consent procedure.
  • All patients hospitalized at Cedars-Sinai Medical Center with AIDS and possible Pneumocystis carinii pneumonia (PCP) will be eligible.
  • Patients with HIV antibody or AIDS and a clinical presentation suggesting PCP are eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LyphoMed Inc

Rosemont, Illinois, 60018, United States

Location

Related Publications (2)

  • Soo Hoo GW, Mohsenifar Z, Meyer RD. Inhaled or intravenous pentamidine therapy for Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):195-202. doi: 10.7326/0003-4819-113-3-195.

    PMID: 2197910BACKGROUND

  • Conte JE Jr, Chernoff D, Feigal DW Jr, Joseph P, McDonald C, Golden JA. Intravenous or inhaled pentamidine for treating Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):203-9. doi: 10.7326/0003-4819-113-3-203.

    PMID: 2197911BACKGROUND

MeSH Terms

Conditions

Pneumonia, PneumocystisHIV InfectionsAIDS-Related Opportunistic InfectionsRespiratory AspirationAcquired 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 InfectionsRespiration DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

BenzamidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
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: 1989-08

Locations

US(1)