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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00158821
First received: September 7, 2005
Last updated: June 21, 2013
Last verified: June 2013

September 7, 2005
June 21, 2013
March 2000
December 2001   (final data collection date for primary outcome measure)
  • To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48. [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 144 Weeks ] [ Designated as safety issue: Yes ]
    compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure
  • 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.
Complete list of historical versions of study NCT00158821 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: 336 Weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 480 Weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 624 Weeks ] [ Designated as safety issue: Yes ]
    evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 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.
Not Provided
Not Provided
 
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.
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)

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Viread (tenofovir disoproxil fumarate)
    Tenofovir DF 300 mg tablets once daily
    Other Name: Viread
  • Drug: Sustiva (Efavirenz)
    efavirenz capsules 600 mg once daily
    Other Name: Sustiva
  • Drug: Epivir (Lamivudine)
    lamivudine 150 mg tablets twice daily
    Other Name: Epivir
  • Drug: Zerit (Stavudine) Placebo
    stavudine placebo capsules twice daily
    Other Name: Zerit
Not Provided
Valdez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
June 2013
December 2001   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00158821
GS-99-903
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Erin Quirk, M.D. Gilead Sciences
Gilead Sciences
June 2013

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