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Objective: To determine whether dronabinol affects appetite and weight status in patients living with HIV/AIDS., Methods: A retrospective chart review was conducted to analyze weight and appetite changes and nausea status in patients with HIV/AIDS who received dronabinol for 3 to 12 months from January 11, 1993, to March 17, 2003., Results: Of the 117 patients who lost weight before baseline, 63% maintained or gained weight. In patients receiving dronabinol for 1 year, the mean weight gain (+/- SD) was 3.7 +/- 10.6 lb. The percentage of patients experiencing loss of appetite decreased significantly from 71% at baseline to 26% at 1 month (P < .001) and continued to decline throughout the trial. The percentage of patients experiencing nausea at baseline (38%) decreased consistently from week 2 on; this change from baseline was significant at month 6 (P = .031)., Conclusion: When taken for 3 months to 1 year, dronabinol significantly improves appetite and reverses weight loss in patients living with HIV/AIDS.

Background: GS-9137 is a potent low-nanomolar strand transfer inhibitor of HIV-1 integrase., Methods: The antiviral activity, tolerability, pharmacokinetics, and pharmacodynamics of GS-9137 were evaluated in a randomized, double-blind, placebo-controlled monotherapy study in 40 HIV-1- infected patients not receiving antiretroviral therapy with an HIV-1 RNA between 10,000 and 300,000 copies/mL and a CD4 count of 200 cells/microL or greater. GS-9137 or matching placebo was administered with food for 10 days at 5 dosage regimens (200, 400, or 800 mg BID, 800 mg QD, or 50 mg+100 mg ritonavir QD; 6 active, 2 placebo per dose level). The primary end point was the maximum reduction from baseline in log10 HIV-1 RNA., Results: Forty patients were enrolled, with a mean baseline viral load of 4.75 log10 copies/mL and a CD4 count of 442 cells/microL. Each GS-9137 dosing regimen exhibited significant, exposure-dependent (mean reductions, -0.98 to -1.99 log10 copies/mL) antiviral activity compared with placebo (P<0.01). Twice-daily administrations of GS-9137 at doses of 400 or 800 mg or once-daily dosing of 50 mg with ritonavir demonstrated mean reductions from baseline in HIV-1 RNA of 1.91 log10 copies/mL or greater, with all patients exhibiting 1 log10 or greater and 50% having 2 log10 or greater reductions. No patient developed evidence of integrase resistance. GS-9137 showed an adverse event profile similar to placebo, and there were no study drug discontinuations., Conclusions: GS-9137 demonstrated substantial short-term antiviral activity and was well tolerated as monotherapy, thus warranting further study.

Fosamprenavir (FPV) with and without ritonavir (RTV) was added to the antiretroviral regimens of human immunodeficiency virus-infected subjects receiving nevirapine (NVP) to evaluate this drug interaction. Significant reductions in plasma amprenavir exposure (25 to 35%) were observed following coadministration of 1,400 mg of FPV twice a day (BID) and 200 mg of NVP BID. A regimen of 700 mg of FPV BID plus 100 mg of RTV BID may be coadministered with NVP without dose adjustment.