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Tenofovir Disoproxil Fumarate (DF)/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
This study is ongoing, but not recruiting participants.
Study NCT00112047   Information provided by Gilead Sciences
First Received: May 27, 2005   Last Updated: March 3, 2009   History of Changes

May 27, 2005
March 3, 2009
August 2003
 
Assess non-inferiority of Tenofovir DF/Emtricitabine/Efavirenz compared to Combivir/Efavirenz as determined by the proportion of patients with HIV RNA less than 400 c/mL at week 48 using the time to loss of virologic response (TLOVR) algorithm.
Same as current
Complete list of historical versions of study NCT00112047 on ClinicalTrials.gov Archive Site
Evaluate safety and efficacy in 2 treatment regimens thru 144 weeks
Same as current
 
Tenofovir Disoproxil Fumarate (DF)/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
Phase 3/Randomized/Open-Label Study of the Treatment of Antiretroviral-Naive HIV-1-Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs. Combivir (Lamivudine/Zidovudine) and Efavirenz

The purpose of this study is to assess two regimens in antiretroviral-naive subjects.

The purpose of this study is to assess two regimens in antiretroviral-naive subjects.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
HIV Infections
  • Drug: Viread (tenofovir disoproxil fumarate )
  • Drug: Emtriva (emtricitabine)
  • Drug: Combivir (zidovudine + lamivudine)
  • Drug: Sustiva (efavirenz)
 
Gallant JE, DeJesus E, Arribas JR, Pozniak AL, Gazzard B, Campo RE, Lu B, McColl D, Chuck S, Enejosa J, Toole JJ, Cheng AK; Study 934 Group. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006 Jan 19;354(3):251-60.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
500
August 2009
 

Inclusion Criteria: Subjects must meet all inclusion criteria within 28 days prior to randomization unless specified otherwise:

  • Plasma HIV-1 RNA levels greater than 10,000 copies/mL using Roche Amplicor HIV-1 Monitor Test Version 1.5 Standard
  • Adequate renal function: Calculated creatinine clearance greater than or equal to 50 mL/min according to Cockcroft-Gault Formula.
  • Hepatic transaminases (AST and ALT) less than or equal to 3 x upper limit of normal (ULN).
  • Total bilirubin less than or equal to 1.5 mg/dL.
  • Adequate hematologic function (absolute neutrophil count greater than or equal to 1,000/mm3; platelets greater than or equal to 50,000/mm3; hemoglobin greater than or equal to 8.0 g/dL).
  • Serum amylase less than or equal to 1.5 x ULN.
  • Serum phosphorus greater than or equal to 2.2 mg/dL.
  • Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drug completion.
  • Life expectancy greater than or equal to 1 year
  • The ability to understand and sign written informed consent form obtained prior to initiation of study procedures.

Exclusion Criteria: Subjects are not eligible for study if any of the following are met:

  • Prior treatment with any non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), or protease inhibitor (PI).
  • A new AIDS-defining condition diagnosed (exception CD4 criteria) within 30 days of baseline.
  • Receiving ongoing therapy with any of the following: nephrotoxic agents, probenecid, systemic chemotherapeutic agents, systemic corticosteroids, interleukin-2, drugs that interact with efavirenz. Administration of any of the above medications must be discontinued at least 30 days prior to baseline visit and for duration of study.
  • Pregnant or lactating subjects.
  • Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Subjects with biopsy confirmed KS are eligible but must not have received any systemic therapy for KS within 30 days of baseline and not anticipate starting systemic therapy during the study.
  • Prior history of renal or bone disease.
  • Any other clinical condition prior to therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements in the opinion of the investigator.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112047
 
GS-01-934
Gilead Sciences
 
Study Director: Andrew Cheng, MD, PhD Gilead Sciences
Gilead Sciences
March 2009

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