Status:

COMPLETED

Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Pneumonia, Pneumocystis Carinii

HIV Infections

Eligibility:

All Genders

1-12 years

Phase:

PHASE1

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...

Detailed Description

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 a...

Eligibility Criteria

Inclusion Criteria

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:

  • Prophylactic TMP/SMX if given no less than 3 days prior to study entry.
  • Prophylactic aerosolized pentamidine (or a single intravenous dose of 4.0 mg/kg pentamidine) if given no less than 7 days prior to study entry.

Exclusion Criteria

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.
  • Dapsone.
  • Benzodiazepines.
  • Rifampin.
  • Erythromycin, clarithromycin, and azithromycin.
  • Digitalis.
  • Para-aminosalicylic acid (PAS).
  • Isoniazid.
  • Anticoagulants.
  • Any other investigational therapies.

Patients with the following prior condition are excluded:

  • History of G6PD deficiency.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

September 1 1996

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00000773

End Date

September 1 1996

Last Update

October 28 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

UCSF Pediatric AIDS CRS

San Francisco, California, United States, 94143

2

Chicago Children's CRS

Chicago, Illinois, United States, 60614

3

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, United States

4

DUMC Ped. CRS

Durham, North Carolina, United States