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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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