A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00053638

Enrollment

345

Registered

2003-02-05

Start date

2003-02-28

Completion date

2004-10-31

Last updated

2010-10-04

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

Conditions

HIV Infection

Keywords

HIV-1 Efavirenz Tenofovir

Brief summary

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Interventions

DRUGefavirenz

DRUGtenofovir

DRUGabacavir/lamivudine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants must be able to provide informed consent. * Have documented HIV-1 infection. * Have not received more than 14 days of prior treatment with antiretroviral drugs. * Meet laboratory test criteria. * Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception. * Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria

* Enrolled in other HIV treatment studies. * Pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Viral load response at 48 weeks	48 weeks

Secondary

Measure	Time frame
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics	48 weeks

Countries

United States

Outcome results

None listed

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