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COMPLETED Phase 4

Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

NCT00940771 · View on ClinicalTrials.gov ↗

Study Summary

The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this study, children who have high cholesterol or high triglycerides as a result of their HIV medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of Atazanavir and Ritonavir will be according to the Package Insert for this drug that is FDA approved for children. They will continue taking the other medications from the pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue study drug after the study using commercially available drug. Lab tests and a physical exam will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how effective the new drug is and to monitor for possible side effects.

Interventions

  • DRUG Boosted Atazanavir

Study Locations (1)

Arizona

  • Phoenix Children's Hospital — Phoenix

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-08-26
Est. Completion 2016-11-23
Phase Phase 4

Sponsor

Phoenix Children's Hospital

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00940771

The ClinicalTrials.gov registry entry for NCT00940771 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Phoenix Children's Hospital, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention — of which Boosted Atazanavir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00940771 reports 1 study location spanning 1 distinct geographic area — top geographies include Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00940771 about?

NCT00940771 is a clinical study titled "Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens". The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and...

What is the current status of trial NCT00940771?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2009-08-26. Estimated completion is 2016-11-23.

What conditions does trial NCT00940771 study?

This clinical trial studies the following conditions: HIV Infections, Pediatric HIV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00940771?

The interventions under investigation include: Boosted Atazanavir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00940771?

This trial is sponsored by Phoenix Children's Hospital, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00940771 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial