A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.
Baseline to Week 48
No
Thomas J Podsadecki, MD
Study Director
Abbott
United States: Food and Drug Administration
M10-336
NCT00711009
July 2008
October 2010
Name | Location |
---|---|
Site Reference ID/Investigator# 8431 | Phoenix, Arizona 85006 |
Site Reference ID/Investigator# 8432 | Beverly Hills, California 90211 |
Site Reference ID/Investigator# 8394 | Atlantis, Florida 33462 |
Site Reference ID/Investigator# 8393 | Fort Pierce, Florida 34982 |
Site Reference ID/Investigator# 8425 | Orlando, Florida 32803 |
Site Reference ID/Investigator# 8402 | Tampa, Florida 33614 |
Site Reference ID/Investigator# 8396 | Vero Beach, Florida 32960 |
Site Reference ID/Investigator# 8395 | Atlanta, Georgia 30303 |
Site Reference ID/Investigator# 8429 | Decatur, Georgia 30033 |
Site Reference ID/Investigator# 8424 | Boston, Massachusetts 02215 |
Site Reference ID/Investigator# 8426 | Charlotte, North Carolina 28209 |
Site Reference ID/Investigator# 11461 | Huntersville, North Carolina 28078 |
Site Reference ID/Investigator# 8403 | Dallas, Texas 75246 |
Site Reference ID/Investigator# 8433 | Houston, Texas 77004 |