ABSTRACT
PURPOSE: To compare the long-term clinical efficacy and toxicity of initial strategies of nelfinavir (NFV) or ritonavir (RTV) in patients with CD4+ cells below 200/mm3. METHOD: This was an open-label randomized multicenter trial (CPCRA, CTN). Patients were naïve to protease inhibitor use except for hard gel saquinavir. Patients who were intolerant to their assigned therapy were allowed to switch arms (later RTV-intolerant patients could switch to indinavir). The primary objective was to compare the regimens for AIDS-defining conditions and death (AIDS/death) using intent-to-treat analysis. Hazard ratios (HR) for NFV and RTV were estimated using Cox's proportional hazards models. Kaplan-Meier life table summaries were also used to compare the two groups. RESULTS: There were 775 patients who were randomized beginning in January 1997 and followed through December 2001. At entry, mean CD4+ cell count was 58 cells/mm3 and HIV RNA level averaged 4.9 log copies/mL. After a median follow-up of 52 months, rates of AIDS/death were 12.7 and 11.0 per 100 person years for the NFV and RTV groups, respectively (HR=1.16; 95% CI, 0.92-1.46; p=.21). Discontinuations occurred earlier in the RTV group (p=.0001). CONCLUSION: There are moderate differences in efficacy and large differences in tolerability between a strategy of initial NFV or RTV in patients with advanced disease. Finding the right balance between potency and tolerability remains a challenge.
Subject(s)
HIV Infections/drug therapy , HIV Infections/virology , HIV Protease Inhibitors/therapeutic use , Nelfinavir/therapeutic use , Ritonavir/therapeutic use , Adult , CD4 Antigens/blood , Drug Therapy/statistics & numerical data , Female , Follow-Up Studies , HIV Protease Inhibitors/administration & dosage , Humans , Male , Nelfinavir/administration & dosage , Proportional Hazards Models , Quality of Life , RNA, Viral/blood , Ritonavir/administration & dosage , Severity of Illness IndexABSTRACT
The brachial artery has been considered a secondary choice for percutaneous access due to reported increased complication rates compared to femoral access despite potential advantages in peripheral vascular disease (PVD) patients. A prospectively collected database of 1326 PVD patients undergoing angiography with percutaneous brachial access between January 1, 1990 and December 31, 1999 was retrospectively reviewed. All patient charts with coded brachial pathology during this time period were reviewed to ensure complete data capture. The protocol for patients undergoing brachial access included a vascular surgery evaluation after each angiogram and telephone follow-up by a nurse at 24 hr. During this 10-year period, a percutaneous brachial artery approach was used to perform 1084 angiograms in men and 242 angiograms in women. A subset of 111 patients had multiple studies (range: 2 to 7) via brachial access without complication. Rates of failed access (2.1% female vs. 0% male, p <0.001) and brachial thrombosis (1.24% female vs. 0.28% male, p <0.04) were significantly higher in women. The complication rate for all patients was 1.28%. Percutaneous brachial access for angiography can be safely and repetitively performed in PVD patients, although women have an increased risk of thrombosis and failed access. The brachial approach allows early ambulation and discharge, and can be considered a primary choice for diagnostic angiographic access.
