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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.

NCT00158821 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2013-06-25

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Viread (tenofovir disoproxil fumarate)

Tenofovir DF 300 mg tablets once daily

DRUG

Sustiva (Efavirenz)

efavirenz capsules 600 mg once daily

DRUG

Epivir (Lamivudine)

lamivudine 150 mg tablets twice daily

DRUG

Zerit (Stavudine) Placebo

stavudine placebo capsules twice daily

Sponsors & Collaborators

Principal Investigators

  • Erin Quirk, M.D. · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2001-12-31
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00158821 on ClinicalTrials.gov