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A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00053638
First Posted: February 5, 2003
Last Update Posted: October 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
February 4, 2003
February 5, 2003
October 4, 2010
February 2003
October 2004   (Final data collection date for primary outcome measure)
Viral load response at 48 weeks [ Time Frame: 48 weeks ]
Not Provided
Complete list of historical versions of study NCT00053638 on ClinicalTrials.gov Archive Site
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics [ Time Frame: 48 weeks ]
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A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infection
  • Drug: efavirenz
  • Drug: tenofovir
  • Drug: abacavir/lamivudine
    Other Names:
    • efavirenz
    • tenofovir
Not Provided
Underwood MR, Ross LL, Irlbeck DM, Gerondelis P, Rouse E, St Clair MH, Trinh L, Parkin N, Lanier E. Sensitivity of phenotypic susceptibility analyses for nonthymidine nucleoside analogues conferred by K65R or M184V in mixtures with wild-type HIV-1. J Infect Dis. 2009 Jan 1;199(1):84-8. doi: 10.1086/595296.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
October 2004
October 2004   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Participants must be able to provide informed consent.
  • Have documented HIV-1 infection.
  • Have not received more than 14 days of prior treatment with antiretroviral drugs.
  • Meet laboratory test criteria.
  • Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
  • Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

  • Enrolled in other HIV treatment studies.
  • Pregnant or breastfeeding.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00053638
ESS30009
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Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP