A pilot study of sequential therapy with zidovudine plus acyclovir, dideoxyinosine, and dideoxycytidine in patients with severe human immunodeficiency virus infection.
A pilot study was initiated to explore a sequential combination antiretroviral regimen in 21 patients with AIDS or advanced human immunodeficiency virus (HIV) infection, who had received little or no prior anti-HIV therapy. The mean entry CD4 cell count was 184/mm3. Patients received 3-week cycles consisting of zidovudine plus acyclovir, dideoxyinosine, and dideoxycytidine for 1 week each. Overall, the regimen was well tolerated for up to 3 years. The principal toxicities were anemia, nausea, and vomiting; 1 patient developed retinal lesions. The mean CD4 cell count reached a peak of 64 cells/mm3 above baseline at week 8 (P = .005 compared to baseline) and remained above baseline for > 40 weeks. Patients also gained weight and had decreases in serum HIV p24 antigen. Eight patients developed opportunistic infections or tumors. Only 4 patients died during 3 years of follow-up. This regimen appears to be generally tolerable and to have anti-HIV activity. Additional studies will be needed, however, to learn how to best combine the available agents in patients with HIV infection.
Nguyen
B Y
BY
Medicine Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892.
Shay
L E
LE
Wyvill
K M
KM
Pluda
J M
JM
Brawley
O
O
Cohen
R B
RB
Whitcup
S M
SM
Venzon
D J
DJ
Broder
S
S
Yarchoan
R
R
D000386:AIDS-Related Complex / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D000212:Acyclovir / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D015703:Antigens, CD / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001835:Body Weight; D015704:CD4 Antigens / Q000097:blood; D016049:Didanosine / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D016655:HIV Core Protein p24 / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016176:T-Lymphocyte Subsets / Q000276:immunology; D013997:Time Factors; D016047:Zalcitabine / Q000008:administration & dosage / Q000627:therapeutic use*; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use*
D015703:Antigens, CD; D015415:Biomarkers; D015704:CD4 Antigens; D016655:HIV Core Protein p24; D015215:Zidovudine; D016047:Zalcitabine; D016049:Didanosine; D000212:Acyclovir