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NCT01335698 · ClinicalTrials.gov registry record · Phase 3

Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients

A Phase 3 study of HIV, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
160
Enrollment target
20
Study locations

NCT01335698 is a Phase 3 study of HIV that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 160 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01335698, a Phase 3 study of HIV, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
160 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.

Conditions Studied

Interventions

  • DRUG Ritonavir
  • DRUG Atazanavir Sulphate

Study Locations (20)

Other

  • Local Institution - Oaxaca City
  • Local Institution - Puebla City
  • Local Institution - Warsaw
  • Local Institution - Bucharest
  • Local Institution - Saint Petersburg
  • Local Institution - Saint Petersburg

Buenos Aires

  • Local Institution - Buenos Aires, Bs As
  • Local Institution - Bunos Aires

Rio Grande do Sul

  • Local Institution - Porto Alegre
  • Local Institution - Porto Alegre

Santiago Metropolitan

  • Local Institution - Santiago
  • Local Institution - Santiago

Jalisco

  • Local Institution - Guadalajara
  • Local Institution - Guadalajara

District of Columbia

  • Children'S National Medical Center - Washington D.C.

New York

  • SUNY Upstate Medical University - Syracuse

Pernambuco

  • Local Institution - Recife

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2011-05-27
Est. Completion 2018-01-22
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT01335698

The ClinicalTrials.gov registry entry for NCT01335698 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 439-participant average among 303 other HIV trials with a reported enrollment target (64% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Ritonavir is the first listed.

NCT01335698 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Buenos Aires, Rio Grande do Sul.

Frequently Asked Questions

What is clinical trial NCT01335698 about?

NCT01335698 is a clinical study titled "Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients". The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.

What is the current status of trial NCT01335698?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2011-05-27. Estimated completion is 2018-01-22.

What conditions does trial NCT01335698 study?

This clinical trial studies the following conditions: HIV.

What interventions are being tested in trial NCT01335698?

The interventions under investigation include: Ritonavir (DRUG), Atazanavir Sulphate (DRUG).

Who is sponsoring clinical trial NCT01335698?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01335698 being conducted?

This trial has 20 study locations across District of Columbia, New York, Buenos Aires, Pernambuco, Rio Grande do Sul. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.