Evaluation of the efficacy of Combivir + Stocrin for the treatment of HIV-1 infected people in a rural area of China
Objectives: China CIPRA is an integrated AIDS research project funded by the US NIH to evaluate the efficacy, safety and tolerability of Combivir and efavirenz (Stocrin) administered for 52 weeks to HIV-1-infected patients in a rural area of China.
Methods: From May 2005 to Feb 2006, 100 HIV-1 infected, ART-naïve patients with CD4 <350cells/µl were enrolled. Patients received lamivudine 150 mg/zidovudine 300 mg twice daily + efavirenz 600 mg daily for 52 weeks. Follow-up visits were performed on weeks 0, 1, 2, 3, 4, 8, 12, 24, 36, 48 and 52. Adverse effects were coded using MeDRA.
Results: Mean baseline CD4 and viral load (VL) were 210 cells/µl and 4.47 log10 copy/ml, respectively, compared to 285 cells/µl and 2.93 log10 copy/ml at week 36. 72% had VL<400 copy/ml at week 36. Thirteen Grade 3 or 4 adverse events were reported, including anemia (7); abnormal liver function (2); skin rash (1); visual disturbance (1); diabetic ketoacidosis (1); heart failure (1); and cognitive behavioral/attention disorder (1). By 1/31/07, 94 patients were off study and had been referred to the free National ART program. Sixty-six participants completed the one-year study while 28 subjects withdrew [adverse events (13), virologic failure (8), poor adherence (1), and refused further participation (6)]. Laboratory quality was monitored by external proficiency testing (CAP, USA; NCCL, China). Data quality was maintained by site monitoring. Clinical treatment quality was maintained through frequent visits by Beijing-based investigators.
Conclusions: Treatment of HIV with Combivir and Stocrin is safe, effective, and well tolerated in rural China. Most of the adverse events were mild and resolved with ongoing treatment. Anemia due to zidovudine was the main reason for treatment discontinuation. Rural hospitals in China can conduct international level HIV/AIDS research with intensive support from the national level.
Zhang T.1, Chen X.2, Liu Z.3, Zhou F.4, Zhu H.5, Chen J.6, Wang W.6, Mei S.4, Li L.4, Wei F.4, Qiao X.7, Zhang L.4, Zhao X.6, Dong X.4, Sun Z.8, Wang J.9, Li H.9, Jiao J.H.10, Chamberlin J.10, Chen R.11, Pettinelli C.11, Li T.3, Cao Y.4
Beijing Youan Hospital affiliated to Capital Medical University