This protocol features a multicenter,open-label design which will evaluate safety, tolerance and antiviral efficacy. HIV-1+ males and females 14 years of age or older with HIV-1 RNA levels < or = 400 copie/mL newly enrolled patients from protocol M/3331/0021 will be treated with delavirdine (400 mg TID), zidovudine (200 mg TID) and lamivudine (150 mg based on body weight). (This extension study consists of a single dosage group to be treated for 24 weeks with the option of continuing study participation for an additional 24 weeks if study participants remain < or= 400 copies.mL in viral load). Safety will be assessed at every 8 weeks. Viral burden will be measured by an FDA approved RNA PCR assay, and results will be provided to the investigators as baseline (which is M/3331/0021 end of study visit), weeks 8,16,24 (32,40,48 and early D/C ). This will be provided to investigators to assist in treatment decisions.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000750-27S3
Application #
6265126
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
27
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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