An Evaluation Of The Safety And Efficacy Of Combivir^(R) (3TC 150mg/ZDV 300mg) Tablets And Agenerase(R) (Amprenavir) (APV 150mg) Capsules In HIV Positive Patients In Three Tertiary Hospitals In Nigeria *I B Keshinro, +J Idoko, **A S Akanmu A,**C C Okanny, ++W Kodjo-Soroh, ++A Davies.

SUMMARY

Objective: The study was an open labeled non-comparative study to evaluate the safety and efficacy of combining CombivirTM (3TC 150mg/ZDV 300mg) tablets and AgeneraseTM (Amprenavir) (APV 150mg) capsules in the treatment of HIV positive patients with CD4 cell counts of 100 - 500/mm3 .

Methods: Sixty-four patients aged 22 to 65 years received CombivirTM 450mg b.d. and AgeneraseTM 1200mg b.d. dispensed 4-weekly over a twenty-four week period.

Results: Ninety percent of the patients showed immunological response to therapy with the mean CD4+ cell count of the patients rising from 254 cells/mm3 at the beginning of the study to 494 cells/mm3 at the end (p=0.0000032). The patients also experienced weight gain and improvement in quality of life. Few side effects were reported. These were mainly gastrointestinal, mild and self-limiting. No significant laboratory abnormalities were noted in most patients

Conclusions It was concluded that the combination of CombivirTM (3TC 150mg/ZDV 300mg) tablets and AgeneraseTM (Amprenavir) (APV 150mg) capsules was safe and efficacious in the treatment of HIV positive patients with CD4 cell counts of 100 - 500/mm3. Niger Med J. 2003; Vol 44 (3): 55-59

KEY WORDS: Amprenavir, HIV Infection, Therapy.