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.
Medicine Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892.
B Y
BY
Nguyen
L E
LE
Shay
K M
KM
Wyvill
J M
JM
Pluda
O
O
Brawley
R B
RB
Cohen
S M
SM
Whitcup
D J
DJ
Venzon
S
S
Broder
R
R
Yarchoan
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