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Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Viread (tenofovir disoproxil fumarate)
Sustiva (Efavirenz)
Epivir (Lamivudine)
Zerit (Stavudine) Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Antiretroviral, Treatment Experienced, HIV-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Completed the original 96-weeks of open-label treatment. Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drugs completion. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures related to the second 96-week open-label phase extension. Exclusion Criteria: Patients requiring therapy with any of the following: Nephrotoxic agents (aminoglycoside antibiotics, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, oral and IV vancomycin, oral and IV ganciclovir, other agents with significant nephrotoxic potential);Probenecid; Systemic chemotherapeutic agents; Systemic corticosteroids; Interleukin-2 (IL-2); Investigational agents (except on approval by Gilead Sciences); Drugs that interact with efavirenz (astemizole, terfenadine, dihydroergotamine, ergotamine, midazolam, triazolam, cisapride, rifampin, ergonovine, methylergonovine, voriconazole). Administration of any of the listed medications is not allowed throughout the duration of the study period. Pregnant or lactating patients. Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication. Current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance. Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, if they are not anticipated to require systemic therapy during the study. Active, serious infections(other than HIV-1 infection) requiring parenteral antibiotic therapy. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48.
    compare the two treatment groups with the goal of achieving HIV-1 RNA levels
    To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure.
    compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure

    Secondary Outcome Measures

    To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.
    evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure
    To evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
    evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
    To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure.
    evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    June 21, 2013
    Sponsor
    Gilead Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00158821
    Brief Title
    Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.
    Official Title
    A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.(Extension)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2000 (undefined)
    Primary Completion Date
    December 2001 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gilead Sciences

    4. Oversight

    5. Study Description

    Brief Summary
    To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral drugs and have a viral load of less than 400 copies/mL at week 48.
    Detailed Description
    To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48. To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure. To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    HIV, Antiretroviral, Treatment Experienced, HIV-1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Viread (tenofovir disoproxil fumarate)
    Other Intervention Name(s)
    Viread
    Intervention Description
    Tenofovir DF 300 mg tablets once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Sustiva (Efavirenz)
    Other Intervention Name(s)
    Sustiva
    Intervention Description
    efavirenz capsules 600 mg once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Epivir (Lamivudine)
    Other Intervention Name(s)
    Epivir
    Intervention Description
    lamivudine 150 mg tablets twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Zerit (Stavudine) Placebo
    Other Intervention Name(s)
    Zerit
    Intervention Description
    stavudine placebo capsules twice daily
    Primary Outcome Measure Information:
    Title
    To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48.
    Description
    compare the two treatment groups with the goal of achieving HIV-1 RNA levels
    Time Frame
    Week 48
    Title
    To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure.
    Description
    compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure
    Time Frame
    144 Weeks
    Secondary Outcome Measure Information:
    Title
    To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.
    Description
    evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure
    Time Frame
    336 Weeks
    Title
    To evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
    Description
    evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
    Time Frame
    480 Weeks
    Title
    To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure.
    Description
    evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure
    Time Frame
    624 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completed the original 96-weeks of open-label treatment. Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drugs completion. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures related to the second 96-week open-label phase extension. Exclusion Criteria: Patients requiring therapy with any of the following: Nephrotoxic agents (aminoglycoside antibiotics, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, oral and IV vancomycin, oral and IV ganciclovir, other agents with significant nephrotoxic potential);Probenecid; Systemic chemotherapeutic agents; Systemic corticosteroids; Interleukin-2 (IL-2); Investigational agents (except on approval by Gilead Sciences); Drugs that interact with efavirenz (astemizole, terfenadine, dihydroergotamine, ergotamine, midazolam, triazolam, cisapride, rifampin, ergonovine, methylergonovine, voriconazole). Administration of any of the listed medications is not allowed throughout the duration of the study period. Pregnant or lactating patients. Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication. Current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance. Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, if they are not anticipated to require systemic therapy during the study. Active, serious infections(other than HIV-1 infection) requiring parenteral antibiotic therapy. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erin Quirk, M.D.
    Organizational Affiliation
    Gilead Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18042503
    Citation
    Madruga JR, Cassetti I, Suleiman JM, Etzel A, Zhong L, Holmes CB, Cheng AK, Enejosa J; Study 903E Team. The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy. HIV Clin Trials. 2007 Nov-Dec;8(6):381-90. doi: 10.1310/hct0806-381.
    Results Reference
    derived
    Links:
    URL
    http://www.Gilead.com
    Description
    Gilead website
    URL
    http://www.gileadclinicaltrials.com/pdf/GS-99-903E_synopsis.pdf
    Description
    Study Results

    Learn more about this trial

    Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.

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