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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.
First Received: May 27, 2005   Last Updated: March 3, 2009   History of Changes
Sponsor: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00112047
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Viread (tenofovir disoproxil fumarate )
Drug: Emtriva (emtricitabine)
Drug: Combivir (zidovudine + lamivudine)
Drug: Sustiva (efavirenz)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Evaluate safety and efficacy in 2 treatment regimens thru 144 weeks

Estimated Enrollment: 500
Study Start Date: August 2003
Estimated Study Completion Date: August 2009
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112047

Locations
United States, California
AIDS Healthcare Foundation Research
Beverly Hills, California, United States, 90211
United States, District of Columbia
Capital Medical Associates, P.C.
Washington, District of Columbia, United States, 20036
United States, Florida
Orlando Immunology Center
Orlando, Florida, United States, 32804
United States, Illinois
NorthStar Medical Center
Chicago, Illinois, United States, 60657
United States, North Carolina
Jemsek Clinic
Huntersville, North Carolina, United States, 28078
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Andrew Cheng, MD, PhD Gilead Sciences
  More Information

Additional Information:
Publications:
Study ID Numbers: GS-01-934
Study First Received: May 27, 2005
Last Updated: March 3, 2009
ClinicalTrials.gov Identifier: NCT00112047     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 22, 2009