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Survival Experience Among Patients With AIDS Receiving Zidovudine: Title and subTitle BreakFollow-up of Patients in a Compassionate Plea Program FREE

Terri Creagh-Kirk, MS; Peggy Doi; Elizabeth Andrews, MPH; Sandra Nusinoff-Lehrman, MD; Hugh Tilson, MD; Dan Hoth, MD; David W. Barry, MD
[+] Author Affiliations

Reprint requests to Division of EIS, Burroughs wellcome Co, 3030 Cornwallis Rd, Research Triangle Park, NC 27709 (Ms Creagh-Kirk).


JAMA. 1988;260(20):3009-3015. doi:10.1001/jama.1988.03410200065027
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Through a compassionate plea program (Treatment Investigational New Drug), 4805 patients with acquired immunodeficiency syndrome who previously had experienced Pneumocystis carinii pneumonia (PCP) received zidovudine (Retrovir, formerly azidothymidine). Overall survival at 44 weeks after initiation of therapy was 73% ( ± 2.1%). A positive association was found between survival and pretherapy clinical status as defined by hemoglobin level, functional ability, and stage of disease as measured by time since diagnosis of PCP. For patients with baseline hemoglobin levels of 120 g/L or greater, Karnofsky scores of 90 or greater, and PCP diagnosis within 90 days prior to initiation of therapy, 44-week survival was 88%. Adverse clinical experiences associated with zidovudine therapy were consistent with those from a double-blind, placebo-controlled trial. Survival experience of this large and diverse cohort is consistent with, and extends data from, this clinical trial. Comparison with available natural history data suggests that zidovudine therapy is associated with increased 44-week survival of post-PCP patients with acquired immunodeficiency syndrome.

(JAMA 1988;260:3009-3015)

REFERENCES

Fischl MA, Richman DD, Grieco MH, et al:  The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex . N Engl J Med 1987;;317:185-191.
Richman DD, Fischl MA, Grieco MH, et al:  The toxicity of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex . N Engl J Med 1987;;317:191-197.
Young FE, Norris JA, Levitt JA, et al:  The FDA's new procedures for the use of investigational new drugs in treatment . JAMA 1988;;259:2267-2270.
Karnofsky DA, Abelmann WH, Craver LF, et al:  The use of the nitrogen mustards in the palliative treatment of carcinoma . Cancer 1948;;1:634-656.
SAS User's Guide: Statistics , version 5. Cary, NC, SAS Institute, 1985;.
Rothenberg R, Woelfel M, Stoneburner R, et al:  Survival with the acquired immunodeficiency syndrome . N Engl J Med 1987;;317:1297-1302.
AIDS Weekly Surveillance Report . Atlanta, Centers for Disease Control, 1987;.
McGrady GA, Jason JM, Evatt BL:  The course of the acquired immunodeficiency syndrome in the United States hemophilia population . Am J Epidemiol 1987;;126:25-30.
Lemp GF, Barnhart JL, Rutherford GW, et al:  Predictors of survival for AIDS cases in San Francisco III . Presented at the International Conference on AIDS, Washington, DC, June 3,1987 .

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Fischl MA, Richman DD, Grieco MH, et al:  The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex . N Engl J Med 1987;;317:185-191.
Richman DD, Fischl MA, Grieco MH, et al:  The toxicity of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex . N Engl J Med 1987;;317:191-197.
Young FE, Norris JA, Levitt JA, et al:  The FDA's new procedures for the use of investigational new drugs in treatment . JAMA 1988;;259:2267-2270.
Karnofsky DA, Abelmann WH, Craver LF, et al:  The use of the nitrogen mustards in the palliative treatment of carcinoma . Cancer 1948;;1:634-656.
SAS User's Guide: Statistics , version 5. Cary, NC, SAS Institute, 1985;.
Rothenberg R, Woelfel M, Stoneburner R, et al:  Survival with the acquired immunodeficiency syndrome . N Engl J Med 1987;;317:1297-1302.
AIDS Weekly Surveillance Report . Atlanta, Centers for Disease Control, 1987;.
McGrady GA, Jason JM, Evatt BL:  The course of the acquired immunodeficiency syndrome in the United States hemophilia population . Am J Epidemiol 1987;;126:25-30.
Lemp GF, Barnhart JL, Rutherford GW, et al:  Predictors of survival for AIDS cases in San Francisco III . Presented at the International Conference on AIDS, Washington, DC, June 3,1987 .
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