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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158821

Enrollment

180

Registered

2005-09-12

Start date

2000-03-31

Completion date

2013-06-30

Last updated

2013-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Antiretroviral, Treatment Experienced, HIV-1

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.

Interventions

DRUGViread (tenofovir disoproxil fumarate)

Tenofovir DF 300 mg tablets once daily

DRUGSustiva (Efavirenz)

efavirenz capsules 600 mg once daily

DRUGEpivir (Lamivudine)

lamivudine 150 mg tablets twice daily

DRUGZerit (Stavudine) Placebo

stavudine placebo capsules twice daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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	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.	144 Weeks	compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure

Secondary

Measure	Time frame	Description
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	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.	480 Weeks	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.	624 Weeks	evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026