NCT00000773

Brief Summary

To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

6 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

September 1, 1996

Completed
3.2 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

October 28, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

Pneumonia, Pneumocystis CariniiHIV Infections

Keywords

Pneumonia, Pneumocystis cariniiAntifungal AgentsAcquired Immunodeficiency SyndromeAIDS-Related ComplexBiological Availabilityatovaquone

Interventions

AtovaquoneDRUG

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT).
  • Dideoxycytidine (zalcitabine; ddC).
  • Didanosine (ddI).
  • Nonaminoglycoside, nonmacrolide, and nonsulfonamide antibiotics.
  • Factor VIII.
  • IVIG.
  • Patients must have:
  • AIDS, documented HIV infection, perinatal exposure to HIV, or risk of developing PCP.
  • Normal EKG and chest radiograph.
  • No blood or protein on urinalysis.
  • Consent of parent or guardian.
  • Prior Medication:
  • Allowed:
  • +2 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Anticipated organ system or laboratory abnormalities (other than immune system abnormalities) from the primary disease and its treatment during the study.
  • Acute or chronic infections requiring treatment during the study. NOTE:
  • Thrush and herpes labialis are allowed if these conditions do not require treatment.
  • Diarrhea or vomiting.
  • Concurrent Medication:
  • Excluded:
  • Trimethoprim/sulfamethoxazole.
  • Sulfadoxine and pyrimethamine (Fansidar).
  • Primaquine.
  • Aspirin.
  • Amphotericin B.
  • Aminoglycoside antibiotics.
  • Sulfonamides.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCSF Pediatric AIDS CRS

San Francisco, California, 94143, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, United States

Location

DUMC Ped. CRS

Durham, North Carolina, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105, United States

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 00936, Puerto Rico

Location

Related Publications (1)

  • Dorenbaum A, Sadler BM, Xu J, Van Dyke RB, Wei LJ, Moye J, McNamara J, Yogev R, Diaz C, Hughes W. Phase I safety and pharmacokinetics (PK) study of micronized atovaquone (m-ATQ) in HIV exposed or infected infants and children. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:117 (abstract no 288)

    BACKGROUND

MeSH Terms

Conditions

Pneumonia, PneumocystisHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Atovaquone

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 Compounds

Study Officials

  • Hughes W

    STUDY CHAIR

  • Dorenbaum A

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

September 1, 1996

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

US(5)PR(1)