NCT00001028

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

14 active sites

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

Study Completion

Last participant's last visit for all outcomes

June 1, 1994

Completed
5.4 years until next milestone

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

November 1, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

Pneumonia, Pneumocystis CariniiHIV Infections

Keywords

Pneumonia, Pneumocystis cariniiPentamidineDapsoneAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Pentamidine isethionateDRUG
DapsoneDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Community Consortium of San Francisco

San Francisco, California, 94110, United States

Location

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 802044507, United States

Location

Wilmington Hosp / Med Ctr of Delaware

Wilmington, Delaware, 19899, United States

Location

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, 20422, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Wishard Hosp / Indiana Univ Hosp

Indianapolis, Indiana, 46202, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 071032842, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10456, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 972109951, United States

Location

Richmond AIDS Consortium

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • el-Sadr W, Wentworth D, Dehlinger M, Larntz K. Design and implementation of a community-based trial for prophylaxis for P. carinii pneumonia (PCP). Int Conf AIDS. 1993 Jun 6-11;9(1):79 (abstract no WS-B36-2)

    BACKGROUND

MeSH Terms

Conditions

Pneumonia, PneumocystisHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

PentamidineDapsone

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 DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

BenzamidinesAmidinesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • El-Sadr W

    STUDY CHAIR

  • Luskin-Hawk R

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

June 1, 1994

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(14)