Combination treatment with zidovudine, thymosin alpha 1 and interferon-alpha in human immunodeficiency virus infection.
We have investigated the effects of combination therapy with thymosin alpha 1 and natural human lymphoblastoid interferon-alpha in human immunodeficiency virus infection and have shown that in vitro this combination treatment: (1) synergistically stimulated the cytotoxic activity against natural killer-sensitive target cells of lymphocytes collected from human immunodeficiency virus-infected donors and (2) did not interfere with the antiviral activity of zidovudine. We thus studied the effects of combination therapy with thymosin alpha 1, interferon-alpha and zidovudine in patients with CD4+ lymphocytes ranging from 200 to 500/mm3 in a randomized non-blinded study and found that the treatment was well tolerated after 12 months of therapy and was associated with a substantial increase in the number and function of CD4+ T cells. A similar effect was not observed in human immunodeficiency virus patients treated with zidovudine alone or associated with single agents. These data suggest the need for a controlled, double-blind clinical trial, recently initiated with the approval and the support of the Italian Ministry of Health.
Garaci
E
E
Department of Experimental Medicine and Biochemical Sciences, University of Rome Tor Vergata, Italy.
Rocchi
G
G
Perroni
L
L
D'Agostini
C
C
Soscia
F
F
Grelli
S
S
Mastino
A
A
Favalli
C
C
D000328:Adult; D015496:CD4-Positive T-Lymphocytes; D003131:Combined Modality Therapy; D003602:Cytotoxicity, Immunologic / Q000187:drug effects; D004357:Drug Synergism; D005260:Female; D006678:HIV / Q000187:drug effects / Q000502:physiology; D015658:HIV Infections / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D012307:Risk Factors; D000077596:Thymalfasin; D013947:Thymosin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D014779:Virus Replication / Q000187:drug effects; D015215:Zidovudine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
D007155:Immunologic Factors; D016898:Interferon-alpha; D015215:Zidovudine; D013947:Thymosin; D000077596:Thymalfasin