HIV Infections Clinical Trial
Official title:
A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.
| Verified date | July 2008 |
| 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 compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | February 2006 |
| Est. primary completion date | February 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients = 18 years of age infected with HIV - Plasma HIV RNA = 1000 copies/mL and CD4 cell count = 50 cells/mm3 - Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available) - The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL) Exclusion Criteria: - Pregnancy or breastfeeding - Reported virologic failure to two or more antiretroviral regimens - Active AIDS-defined opportunistic infection or disease - Proven or suspected acute hepatitis within 30 days prior to study entry |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Local Institution | Santruce | |
| United States | Local Institution | Atlanta | Georgia |
| United States | Local Institution | Atlantis | Florida |
| United States | Local Institution | Bakersfield | California |
| United States | Local Institution | Berkley | Michigan |
| 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 | Decatur | Georgia |
| United States | Local Institution | East Orange | New Jersey |
| United States | Local Institution | Fort Lauderdale | Florida |
| United States | Local Institution | Galveston | Texas |
| United States | Local Institution | Greenville | North Carolina |
| United States | Local Institution | Hampton | Virginia |
| United States | Local Institution | Harlingen | Texas |
| United States | Local Institution | Hillsborough | New Jersey |
| United States | Local Institution | Hobson City | Alabama |
| United States | Local Institution | Houston | Texas |
| United States | Local Institution | Huntersville | North Carolina |
| United States | Local Institution | Indianapolis | Indiana |
| United States | Local Institution | Jackson | Mississippi |
| United States | Local Institution | Jacksonville | Florida |
| United States | Local Institution | Jersey City | New Jersey |
| United States | Local Institution | Las Vegas | Nevada |
| United States | Local Institution | Little Rock | Arkansas |
| United States | Local Institution | Los Angeles | California |
| United States | Local Institution | Louisville | Kentucky |
| United States | Local Institution | Miami | Florida |
| United States | Local Institution | Miami Beach | Florida |
| United States | Local Institution | Montgomery | Alabama |
| United States | Local Institution | Mt. Vernon | New York |
| United States | Local Institution | New Orleans | Louisiana |
| United States | Local Institution | New York | New York |
| United States | Local Institution | North Miami | Florida |
| United States | Local Institution | Norwalk | Connecticut |
| United States | Local Institution | Oklahoma City | Oklahoma |
| United States | Local Institution | Orlando | Florida |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | Phoenix | Arizona |
| United States | Local Institution | Plantation | Florida |
| United States | Local Institution | Safety Harbor | Florida |
| United States | Local Institution | San Francisco | California |
| United States | Local Institution | San Mateo | California |
| United States | Local Institution | Springfield | Massachusetts |
| United States | Local Institution | St. Louis | Missouri |
| United States | Local Institution | Tampa | Florida |
| United States | Local Institution | Tarzana | California |
| United States | Local Institution | Valhalla | New York |
| United States | Local Institution | Washington | District of Columbia |
| United States | Local Institution | West Hollywood | California |
| United States | Local Institution | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12 | |||
| Secondary | Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96. |
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