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)

Patrocinadores

Patrocinador principal: Gilead Sciences

Fuente Gilead Sciences
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio March 2000
Fecha de Terminación June 2013
Fecha de finalización primaria December 2001
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48. Week 48
To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure. 144 Weeks
Resultado secundario
Medida Periodo de tiempo
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. 336 Weeks
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. 480 Weeks
To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure. 624 Weeks
Inscripción 180
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Viread (tenofovir disoproxil fumarate)

Descripción: Tenofovir DF 300 mg tablets once daily

Otro nombre: Viread

Tipo de intervención: Drug

Nombre de intervención: Sustiva (Efavirenz)

Descripción: efavirenz capsules 600 mg once daily

Otro nombre: Sustiva

Tipo de intervención: Drug

Nombre de intervención: Epivir (Lamivudine)

Descripción: lamivudine 150 mg tablets twice daily

Otro nombre: Epivir

Tipo de intervención: Drug

Nombre de intervención: Zerit (Stavudine) Placebo

Descripción: stavudine placebo capsules twice daily

Otro nombre: Zerit

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Erin Quirk, M.D. Study Director Gilead Sciences
Fecha de verificación

June 2013

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov