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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Viread (tenofovir disoproxil fumarate)
Drug: Sustiva (Efavirenz)
Drug: Epivir (Lamivudine)
Drug: Zerit (Stavudine) Placebo
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

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. [ 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


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. [ 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


Estimated Enrollment: 180
Study Start Date: March 2000
Study Completion Date: June 2013
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158821

Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Erin Quirk, M.D. Gilead Sciences
  More Information

Additional Information:
No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00158821     History of Changes
Obsolete Identifiers: NCT00005573
Other Study ID Numbers: GS-99-903
Study First Received: September 7, 2005
Last Updated: June 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV
Antiretroviral
Treatment Experienced
HIV-1

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

ClinicalTrials.gov processed this record on August 21, 2014