NCT00002340

Brief Summary

To assess whether high dose or low dose atovaquone suspension is more effective than aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients. To compare the safety of chronic administration of the three regimens in patients with advanced HIV disease. To determine the relationship between steady state atovaquone plasma concentrations and prophylactic efficacy against PCP.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
615

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

5 active sites

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, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Pneumonia, Pneumocystis CariniiHIV Infections

Keywords

Pneumonia, Pneumocystis cariniiPentamidineAntifungal AgentsAcquired Immunodeficiency SyndromeAIDS-Related Complexatovaquone

Interventions

AtovaquoneDRUG
Pentamidine isethionateDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Antimicrobial agents not specifically prohibited.
  • Concurrent Treatment:
  • Allowed:
  • Transfusion.
  • Patients must have:
  • HIV positivity.
  • Prior PCP (histologically confirmed) OR documented CD4 count \< 200 cells/mm3 OR constitutional symptoms such as thrush or unexplained fever (\> 100 F) for 2 or more weeks.
  • No current or suspected active PCP, and no signs of active PCP on chest x-ray.
  • Prior intolerance to TMP/SMX or other trimethoprim or sulfa-containing regimens.
  • Life-expectancy of at least 6 months.
  • NOTE:
  • Pregnant women are eligible at the discretion of the investigator.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Significant psychosis or emotional disorder that would preclude study compliance.
  • Severe chronic diarrhea (e.g., \> five stools/day) that may negatively affect absorption of oral medication.
  • Unable to take oral medication or unable or unwilling to take medication with food.
  • Concurrent Medication:
  • Excluded:
  • Rifampin.
  • Other investigational agents except for drugs available through Treatment INDs or expanded access programs.
  • Medications likely to have anti-pneumocystis effect (e.g., dapsone, trimethoprim, pyrimethamine, trimetrexate, other DHFR inhibitors, sulfadiazine, sulfamethoxazole, other sulfonamides, primaquine, clindamycin, and sulfonylureas.
  • Corticosteroids in greater than physiologic replacement doses for more than 21 consecutive days.
  • Systemic therapy for CNS toxoplasmosis, Kaposi's sarcoma, lymphoma, other active malignancies, or other disease that may decrease life expectancy or confound assessment.
  • Patients with the following prior conditions are excluded:
  • History of severe or intractable intolerance to atovaquone or aerosolized pentamidine.
  • Prior hypoglycemia, pancreatitis, arrhythmias, or severe hypotension associated with any form of pentamidine.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Goodgame Med Group

Maitland, Florida, 32751, United States

Location

Bay Area AIDS Consortium

Tampa, Florida, 33609, United States

Location

Saint Vincent's Hosp and Med Ctr

New York, New York, 10011, United States

Location

Holmes Hosp

Cincinnati, Ohio, 452670405, United States

Location

Hampton Roads Med Specialists

Hampton, Virginia, 23666, United States

Location

Related Publications (1)

  • Chan C, Montaner J, Lefebvre EA, Morey G, Dohn M, McIvor RA, Scott J, Marina R, Caldwell P. Atovaquone suspension compared with aerosolized pentamidine for prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected subjects intolerant of trimethoprim or sulfonamides. J Infect Dis. 1999 Aug;180(2):369-76. doi: 10.1086/314893.

    PMID: 10395851BACKGROUND

MeSH Terms

Conditions

Pneumonia, PneumocystisHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

AtovaquonePentamidine

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)

NaphthoquinonesQuinonesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsBenzamidinesAmidines

Study Design

Study Type
interventional
Phase
phase 3
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: 1997-08

Locations

US(5)