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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000773 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Atovaquone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Open Label, Pharmacokinetics Study |
| Official Title: | Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children |
| Estimated Enrollment: | 24 |
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.
Three cohorts of four patients each (ages 2-12 years, 3 months to less than 2 years, and 1 month to less than 3 months) receive atovaquone daily for 12 days. The oldest age group is treated first. In the absence of unacceptable toxicity, the dose of atovaquone is escalated in subsequent 4-patient cohorts representing each of the age stratifications and (per 9/30/94 amendment) in a separate 4-patient cohort aged 3 months to less than 2 years. If two of four patients in a given cohort experience unacceptable toxicity at the initial dose, two additional patients in the same age range are entered. Blood samples are drawn for pharmacokinetic evaluation. Patients are followed to day 24. Per 9/30/94 amendment, patients aged 3 months to less than 2 years of age who received one of the lower doses may re-enroll in the higher dose cohort after a 1-month washout.
Eligibility| Ages Eligible for Study: | 1 Month to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
Contacts and Locations| United States, California | |
| UCSF / Moffitt Hosp - Pediatric | |
| San Francisco, California, United States, 941430105 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hosp of Memphis | |
| Memphis, Tennessee, United States, 381052794 | |
| Puerto Rico | |
| Univ of Puerto Rico / Univ Children's Hosp AIDS | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Hughes W | |
| Study Chair: | Dorenbaum A |
More Information
| Study ID Numbers: | ACTG 227 |
| Study First Received: | November 2, 1999 |
| Last Updated: | January 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00000773 History of Changes |
| Health Authority: | United States: Federal Government |
|
Pneumonia, Pneumocystis carinii Antifungal Agents Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Biological Availability atovaquone |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Pneumonia, Pneumocystis Mycoses Antimalarials Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Retroviridae Infections Lung Diseases, Fungal |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections Atovaquone HIV Infections Lung Diseases Sexually Transmitted Diseases Lentivirus Infections Pneumonia |