This is a roll-over protocol intended to continue availability of study drugs for patients leaving Roche sponsored clinical trials (NV15355, NV15436 and M61003). Patients will continue on the antiretroviral regimen they were receiving on the last day of the Roche sponsored clinical trial preceding the roll-over protocol. The primary objective is to determine time to Virologic Relapse [two HIV-1 RNA > 400 copies/mL $ 10 days apart, following a virologic response (two consecutive values < 400 copies/mL $ 10 days apart)]. Patients will have achieved a virologic response during the Roche sponsored clinical trial preceding the roll-over protocol (as captured at the screening visit). The virologic response starts on the date of the first of the two consecutive values < 400 copies/mL and ends on the date of the first of the two consecutive values > 400 copies/mL. The secondary objective is to determine time to Virologic Relapse [two HIV-1 RNA > 50 copies/mL $ 10 days apart, following a virologic response (two consecutive values < 50 copies/mL days apart)]. Patients will have achieved a virologic response during the Roche sponsored clinical trial preceding the roll-over protocol. The virologic response starts on the date of the first of the two consecutive values < 50 copies/mL and ends on the date of the first of the two consecutive values > 50 copies/mL.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR005096-12
Application #
6458637
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
12
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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