Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135382

Enrollment

254

Registered

2005-08-26

Start date

2002-06-30

Completion date

2005-10-31

Last updated

2010-02-17

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

Conditions

HIV Infections

Keywords

HIV/AIDS

Brief summary

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.

Detailed description

Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.

Interventions

DRUGVidex EC

DRUGEpivir

DRUGSustiva

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

* Documented HIV infection * ≥ 18 years of age and weight at least 40kg * Two plasma HIV RNA levels \< 50 copies/mL during the qualification and screening period * Patients receiving a PI and ≥ 2 NRTIs

Exclusion criteria

* Pregnancy or breastfeeding * Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen * Active AIDS-defining opportunistic infection or disease * Proven or suspected acute hepatitis within 30 days prior to study entry

Design outcomes

Primary

Measure	Time frame
Efficacy at week 48	—

Secondary

Measure	Time frame
Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48	—

Countries

Puerto Rico, United States

Outcome results

None listed

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