Combination therapy with didanosine and interferon-alpha in human immunodeficiency virus-infected patients: results of a phase I/II trial.
A nonrandomized trial was undertaken to evaluate the combination of didanosine and interferon-alpha (INF-alpha) in human immunodeficiency virus (HIV)-infected patients. Thirty-six volunteers with >200 x 10(6) CD4 cells/L received didanosine (one 100-, 250-, or 375-mg sachet twice daily) for at least 6 weeks, following which IFN-alpha (1, 5, 10, or 15 MU/day) was begun. Didanosine (one 375-mg sachet twice daily) was substituted for zidovudine in 14 additional patients who had received IFN-alpha and zidovudine for 7-45 months. Thirty-five patients completed the 34-week study. Clinical or chemical pancreatitis was the most common (6 patients) dose-limiting toxicity. CD4 cell counts increased with didanosine but declined following the addition of IFN-alpha; CD4 cell percents tended to increase and remain elevated. Thus, combination therapy with didanosine and IFN-alpha can be safely administered to patients with HIV infection. The clinical benefit of this combination therapy will require further evaluation.
Kovacs
J A
JA
National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, USA.
Bechtel
C
C
Davey
R T
RT
Falloon
J
J
Polis
M A
MA
Walker
R E
RE
Metcalf
J A
JA
Davey
V
V
Piscitelli
S C
SC
Baseler
M
M
Dewar
R
R
Salzman
N P
NP
Masur
H
H
Lane
H C
HC
D000998:Antiviral Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D016655:HIV Core Protein p24 / Q000378:metabolism; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000254:growth & development; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D010195:Pancreatitis / Q000139:chemically induced; D012367:RNA, Viral / Q000378:metabolism; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage*
D000998:Antiviral Agents; D016655:HIV Core Protein p24; D016898:Interferon-alpha; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D016049:Didanosine