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A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents

NCT00915655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-09-03

Study results available
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Summary

The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected adolescents aged from 12 to \<18 years and weighing at least 40 kg.

Conditions

  • HIV-1 Infection

Interventions

DRUG

darunavir

Type=exact number, unit=mg, number=400, formulation=tablet, route=oral. 2 tablets of darunavir administered once daily for 48 weeks

DRUG

ritonavir

Type=exact number, unit=mg, number=100, formulation=capsule, route=oral. 1 capsule of ritonavir administered once daily for 48 weeks

DRUG

zidovudine

NRTI (zidovudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country

DRUG

lamivudine

NRTI (lamivudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country

DRUG

abacavir

NRTI (abacavir) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country

Sponsors & Collaborators

  • Tibotec Pharmaceutical Limited

    collaborator INDUSTRY

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-09-30
Completion
2011-03-31

Countries

  • United States
  • France
  • Ireland
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915655 on ClinicalTrials.gov