Clinical trial NCT00135369: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-AIDS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Efficacy at week 48
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Hobson City
country: United States
facility: Local Institution
state: Alabama
city: Montgomery
country: United States
facility: Local Institution
state: Alabama
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Sacramento
country: United States
facility: Local Institution
state: California
city: San Mateo
country: United States
facility: Local Institution
state: California
city: Torrance
country: United States
facility: Local Institution
state: California
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Norwalk
country: United States
facility: Local Institution
state: Connecticut
city: Stratford
country: United States
facility: Local Institution
state: Connecticut
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Miami Beach
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Pensacola
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Decatur
country: United States
facility: Local Institution
state: Georgia
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Berkley
country: United States
facility: Local Institution
state: Michigan
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Hackensack
country: United States
facility: Local Institution
state: New Jersey
city: Jersey City
country: United States
facility: Local Institution
state: New Jersey
city: Neptune
country: United States
facility: Local Institution
state: New Jersey
city: Somers Point
country: United States
facility: Local Institution
state: New Jersey
city: Bronx
country: United States
facility: Local Institution
state: New York
city: Manhasset
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Huntersville
country: United States
facility: Local Institution
state: North Carolina
city: Washington
country: United States
facility: Local Institution
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution
state: North Carolina
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Reading
country: United States
facility: Local Institution
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Galveston
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Annandale
country: United States
facility: Local Institution
state: Virginia
city: Hampton
country: United States
facility: Local Institution
state: Virginia
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
References: