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.
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Viread (tenofovir disoproxil fumarate) (Drug); Sustiva (Efavirenz) (Drug); Epivir (Lamivudine) (Drug); Zerit (Stavudine) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
Andrew Cheng, MD, Study Director, Affiliation: Gilead Sciences
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.
Clinical Details
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 design: Treatment
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Gilead website Study Results
Starting date: March 2000
Ending date: February 2006
Last updated: April 7, 2008
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