Clinical trial NCT00135382: Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
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
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: 254
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 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.

Eligibility 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

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: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Beverly Hills
country: United States
facility: Local Institution
state: California
city: Fountain Valley
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Tarzana
country: United States
facility: Local Institution
state: California
city: W. Hollywood
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: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Atlantis
country: United States
facility: Local Institution
state: Florida
city: Daytona Beach
country: United States
facility: Local Institution
state: Florida
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
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: North Miami
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Plantation
country: United States
facility: Local Institution
state: Florida
city: Safety Harbor
country: United States
facility: Local Institution
state: Florida
city: South Miami
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Decatur
country: United States
facility: Local Institution
state: Georgia
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Springfield
country: United States
facility: Local Institution
state: Massachusetts
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: East Orange
country: United States
facility: Local Institution
state: New Jersey
city: Newark
country: United States
facility: Local Institution
state: New Jersey
city: Union
country: United States
facility: Local Institution
state: New Jersey
city: Brooklyn
country: United States
facility: Local Institution
state: New York
city: Manhasset
country: United States
facility: Local Institution
state: New York
city: Mt. Vernon
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Stony Brook
country: United States
facility: Local Institution
state: New York
city: Valhalla
country: United States
facility: Local Institution
state: New York
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Hampton
country: United States
facility: Local Institution
state: Virginia
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Rio Piedras
country: Puerto Rico
facility: Local Institution
Study officials:
References: