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Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

NCT00071760 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-10-10

Study results available
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Summary

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \< 2 years old.

Conditions

  • Infection, Human Immunodeficiency Virus
  • HIV Infections

Interventions

DRUG

GW433908

Fosamprenavir suspension bid

DRUG

ritonavir

Ritonavir solution bid

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-23
Primary Completion
2011-07-05
Completion
2022-03-29

Countries

  • United States
  • Argentina
  • Mexico
  • Portugal
  • Puerto Rico
  • Russia
  • South Africa

Study Locations

More Related Trials

Entities

Companies

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 NCT00071760 on ClinicalTrials.gov