Five-year follow-up of a phase I study of didanosine in patients with advanced human immunodeficiency virus infection.

Abstract

Starting in 1988, 72 patients with advanced human immunodeficiency virus (HIV) infection were enrolled in a phase I study of didanosine at the National Cancer Institute. Beginning in 1992, patients with decreases in CD4 cell counts could switch to a combination of zidovudine and didanosine. The estimated median survival for all patients was 28 months (95% confidence interval, 23-46). However, for patients whose entry CD4 cell counts were 100-300/mm3, the estimated 4-year survival was 80%. Baseline CD4 and CD8 cell counts, hemoglobin, lymphocytes, sedimentation rates, diagnosis of AIDS, and fever were significant predictors of overall survival. Principal toxicities were pancreatitis and peripheral neuropathy; no new toxicities were seen with extended didanosine treatment that had not been observed in shorter-term studies. This 5-year follow-up shows that didanosine can be tolerated for > 4 years in some patients with advanced HIV infection and may have particular long-term utility in patients with moderately advanced immunosuppression.

• Authors: B Y Nguyen, R Yarchoan, K M Wyvill, D J Venzon, J M Pluda, H Mitsuya, S Broder
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 171 Issue 5 Pg. 1180-9 (May 1995) ISSN: 0022-1899 [Print] United States
• PMID: 7751692 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)

Chemical References

• Zidovudine
• Didanosine

Topics

• Adult
• CD4 Lymphocyte Count
• Didanosine (administration & dosage, adverse effects, therapeutic use)
• Disease Progression
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• HIV Infections (drug therapy, immunology, mortality)
• Humans
• Male
• Middle Aged
• Survival Rate
• Zidovudine (therapeutic use)