Five-year follow-up of a phase I study of didanosine in patients with advanced human immunodeficiency virus infection.
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.
Nguyen
B Y
BY
Medicine Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.
Yarchoan
R
R
Wyvill
K M
KM
Venzon
D J
DJ
Pluda
J M
JM
Mitsuya
H
H
Broder
S
S
D000328:Adult; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D015215:Zidovudine / Q000627:therapeutic use
D015215:Zidovudine; D016049:Didanosine