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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006604 |
The purpose of this study is to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV, also known as BMS-232632 or ReyatazTM), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents.
Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option for these patients because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study will try to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, patients will be enrolled in the U.S. and South Africa.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Atazanavir Drug: Ritonavir |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Phase I/II, Open-Label, Pharmacokinetic and Safety Study of a Novel Protease Inhibitor (BMS 232632, Atazanavir, ATV, ReyatazTM) in Combination Regimens in Antiretroviral Therapy (ART)-Naive and -Experienced HIV-Infected Infants, Children, and Adolescents |
Estimated Enrollment: | 157 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part A: Active Comparator
Participants will receive ATV along with 2 other antiretrovirals as determined by study investigators. Participants in this group will be stratified by age and may receive ATV as either a powder or capsule.
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Drug: Atazanavir
protease inhibitor
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Part B: Active Comparator
Participants in this group will receive ATV plus a low-dose RTV booster and 2 other antiretrovirals as determined by study investigators. Participants in this group will be stratified by age and may receive ATV as a powder or capsule.
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Drug: Atazanavir
protease inhibitor
Drug: Ritonavir
protease inhibitor
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Advancements in HAART for HIV infected children and adolescents are hindered by patient nonadherence. The availability of a powder formulation and the once-daily dosing schedule make ATV an attractive agent for improved adherence in pediatric treatment regimens. This study is designed to provide pharmacokinetic (PK) data to guide dosing recommendations for ATV, when given concurrently with or without low-dose RTV boost, in infants, children, and adolescents. During the study, the safety and tolerance of ATV (with or without low-dose RTV) will be closely monitored, and virologic efficacy data will be obtained.
There are two parts to this study. Step I is open in the U.S. and South Africa, and is further divided into two sets of groups, Parts A and B. Part A participants will receive ATV only and Part B participants will receive ATV with low-dose RTV boost. All patients receive ATV once a day with 2 other antiretroviral drugs (not provided by the study), and in Part B patients only (Groups 5 to 8), ATV is given with a low dose of RTV. Patients are placed into 1 of 8 groups (Groups 1 to 4 for Part A; Groups 5 to 8 for Part B) with respect to age and study drug formulation. Patients in Groups 1 and 5 are infants age 3 months and 1 day (91 days) up to 2 years (less than or exactly 730 days) and take ATV in powder form. Patients in Groups 2, 3, 6, and 7 are children age 2 years and 1 day (731 days) or more up to 13 years. Groups 2 and 6 receive ATV in powder form, while Groups 3 and 7 receive the capsule form. Patients in Groups 4 and 8 are adolescents age 13 years and 1 day up to 21 years (not including the 22nd birthday) and take ATV in capsule form. As of 01/02/2008 a new group, 5A has been opened for enrollment. Participants in Group 5A will be age 3 months to 6 months and will take ATV in powder form plus a low dose RTV booster.
For each group, enrollment starts with 5 patients per group, with all patients evaluated for PK and safety criteria, adjusting the dose of ATV until one is found that passes both sets of criteria. Then 5 additional patients are enrolled, with enrollment continuing for each group once all patients within that group meet the PK criteria. For groups receiving RTV (Groups 5 to 8), additional criteria must be met for each dose of ATV studied. In addition to the PK and safety evaluations, 24-hour postdose concentrations (Cmin) will be monitored in the first 10 patients enrolled for a dose of ATV before more patients can be enrolled and studied at that same dose. Clinic visits are every 4 weeks through Week 48, then every 8 weeks until the last patient to enroll in the study has reached Week 96 of his/her treatment. At every visit, patients undergo a complete medical history and physical exam, cardiac conduction evaluation, and urine and blood collection. Patients of childbearing age have a pregnancy test performed at each visit.
Step II is open only to South African participants of Step I who have responded to treatment by the end of Step I. All such participants will be given ATV in capsule form at the same dose they received at the end of Step I, as well as the other antiretrovirals they were receiving during the course of Step I. Step II will continue until ATV is approved in South Africa and readily available by individual prescription, and participants will have a study visit every 12 weeks.
Ages Eligible for Study: | 3 Months to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
[Note: Groups 1,2,3,4,5,6,7, and 8 are no longer open to accrual.]
Exclusion Criteria:
Study Chair: | Richard Rutstein, MD | Children's Hospital of Philadelphia |
Study Chair: | Grace Aldrovandi, MD | Children's Hospital Los Angeles |
Study Chair: | Mark W. Kline, MD | Baylor College of Medicine |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | IMPAACT P1020A, PACTG P1020-A, ACTG P1020-A |
Study First Received: | December 6, 2000 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00006604 |
Health Authority: | United States: Food and Drug Administration |
Dose-Response Relationship, Drug Drug Therapy, Combination Drug Administration Schedule HIV Protease Inhibitors Reverse Transcriptase Inhibitors |
Anti-HIV Agents Pharmacokinetics Treatment Experienced Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Atazanavir Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |