Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

This study has been completed.

First Received: August 25, 2005 Last Updated: June 27, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135369

Purpose

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.

Condition	Intervention	Phase
HIV Infections	Drug: stavudine extended-release, lamivudine, efavirenz	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine Efavirenz Stavudine

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 Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART 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:	300
Study Start Date:	September 2002

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 or older and weigh at least 40 kg
Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Exclusion Criteria:

Pregnancy, breastfeeding or plans to become pregnant during the study period
Any prior documented virologic failure to one or more HAART regimens
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: NCT00135369

Show 50 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional 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

No publications provided

Study ID Numbers:	AI455-135
Study First Received:	August 25, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00135369 History of Changes
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
Stavudine
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009