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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Videx EC Drug: Epivir Drug: Sustiva	Phase III

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Lamivudine Didanosine Efavirenz

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Efficacy at week 48

Secondary Outcome Measures:

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

Estimated Enrollment:	254
Study Start Date:	June 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135382

Show 48 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	AI266-406
First Received:	August 25, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00135382
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV/AIDS

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Sexually Transmitted Diseases, Viral

Didanosine

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135382