Evaluation Oe the Safety and Efficacy Of CombivirTM(3TC 150MG/ZDV 300MG) Tablets AND AgeneraseTM(Amprenavir) (APV 150MG) Capsules in H1V Positive Patients With CD4 Cell Count OF 100 - 300/MM3 in Zaria, Nigeria

The study was an open labeled non-comparative study to evaluate the safety and efficacy of Combivir^TM (3TC 15Omg/ZDV 300mg) tablets and Agenerase^TM (Amprenavir) (APV 150mg) capsules in the treatment of HIV positive patients with CD4 cell counts of 100 - 300/mm³. Twenty-one patients aged 25 to 63 years who met the admission criteria were recruited into the study. There were ten males and eleven females. Informed consent was obtained from each patient. Baseline CD-4 Lymphocyte count, Full Blood Count and Complete Serum Biochemistry were done for each patient. Each patient received combivir^TM 450mg b.d. and Agenerase^TM 1200mg b.d. dispensed 4-weekly over a twenty-four week period. 80.5% of the patients showed an immunological response to therapy with the mean CD4 cell count of the patients rising from 184 cells/mm³ at the beginning of the study to 545 cells/mm³ at the end (p=0.000). The patients also experienced weight gain and improvement in quality of life. Few side effects were reported and these were mainly gastrointestinal. One patient wfthdrew from the study on account of abdominal pain and failure to notice a clinical response after eight weeks of therapy. One patient who was a known diabetic had a worsening of his blood sugar control. This responded to Insulin therapy. No other significant laboratory abnormalities were noted. It was concluded that the combination of Combivir^TM (3TC 15Omg/ZDV 300mg) tablets and Agenerase^TM (Amprenavir) (APV 150mg) capsules was safe and efficacious in the treatment of H1V positive patients with CD4 cell counts of 100 - 300/mm³.