HIV Infections Clinical Trial
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
| Verified date | January 2010 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 254 |
| Est. completion date | October 2005 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Local Institution | Ponce | |
| Puerto Rico | Local Institution | Rio Piedras | |
| United States | Local Institution | Atlanta | Georgia |
| United States | Local Institution | Atlantis | Florida |
| United States | Local Institution | Austin | Texas |
| United States | Local Institution | Beverly Hills | California |
| United States | Local Institution | Boston | Massachusetts |
| United States | Local Institution | Brooklyn | New York |
| United States | Local Institution | Chicago | Illinois |
| United States | Local Institution | Columbia | South Carolina |
| United States | Local Institution | Dallas | Texas |
| United States | Local Institution | Daytona Beach | Florida |
| United States | Local Institution | Decatur | Georgia |
| United States | Local Institution | Denver | Colorado |
| United States | Local Institution | East Orange | New Jersey |
| United States | Local Institution | Fountain Valley | California |
| United States | Local Institution | Ft. Lauderdale | Florida |
| United States | Local Institution | Hampton | Virginia |
| United States | Local Institution | Jacksonville | Florida |
| United States | Local Institution | Kansas City | Missouri |
| United States | Local Institution | Little Rock | Arkansas |
| United States | Local Institution | Long Beach | California |
| United States | Local Institution | Los Angeles | California |
| United States | Local Institution | Manhasset | New York |
| United States | Local Institution | Miami | Florida |
| United States | Local Institution | Miami Beach | Florida |
| United States | Local Institution | Milwaukee | Wisconsin |
| United States | Local Institution | Mt. Vernon | New York |
| United States | Local Institution | New York | New York |
| United States | Local Institution | Newark | New Jersey |
| United States | Local Institution | North Miami | Florida |
| United States | Local Institution | Norwalk | Connecticut |
| United States | Local Institution | Orlando | Florida |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | Plantation | Florida |
| United States | Local Institution | Safety Harbor | Florida |
| United States | Local Institution | San Diego | California |
| United States | Local Institution | San Francisco | California |
| United States | Local Institution | South Miami | Florida |
| United States | Local Institution | Springfield | Massachusetts |
| United States | Local Institution | St. Louis | Missouri |
| United States | Local Institution | Stony Brook | New York |
| United States | Local Institution | Tampa | Florida |
| United States | Local Institution | Tarzana | California |
| United States | Local Institution | Union | New Jersey |
| United States | Local Institution | Valhalla | New York |
| United States | Local Institution | W. Hollywood | California |
| United States | Local Institution | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy at week 48 | |||
| Secondary | 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 |
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