A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination

NCT00335270 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-05-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the antiretroviral efficacy, safety, and tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults

Conditions

Interventions

DRUG

fos-amprenavir calcium, ritonavir

DRUG

abacavir/lamivudine as Epzicom

Sponsors & Collaborators

Principal Investigators

  • Charles Hicks, MD · Duke University

  • Rafael E Campo, MD · University of Miami

  • Jason Flamm, MD · Medicine 4

  • Jeffrey Lennox, MD · Emory University

  • Rodger MacArthur, MD · Wayne State University

  • Jeffrey P Nadler, MD · Hillsborough County Health Department

  • John H. Schrank, MD · Greenville Hospital System

  • Louis Sloan, MD · North Texas Infectious Disease Consultants

  • Jeffrey Stephens, MD · Mercer University School of Medicine

  • David A Wohl, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT00335270 on ClinicalTrials.gov