Effects of zidovudine therapy in minority and other subpopulations with early HIV infection

Stephen Lagakos, Margaret A Fischl, Daniel S. Stein, Lynette Lim, Paul Volberding

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Objective. - The purpose of this study was to determine whether the beneficial effects of zidovudine seen overall in two recently completed placebocontrolled clinical trials are also apparent in blacks, Hispanics, women, and intravenous drug users. Design. - Two double-blind placebo-controlled randomized clinical trials, protocols 016 and 019, conducted by the AIDS Clinical Trials Group. Setting. - University-based referral centers. Participants. - Two thousand forty-eight persons with asymptomatic or mildly symptomatic human immunodeficiency virus infection were analyzed. Of these, 155 were black, 190 were Hispanic, 144 were women, and 221 were intravenous drug users. All randomized subjects were included in the analysis. Intervention. - Participants in the AIDS Clinical Trials Group protocol 016 were assigned to receive a placebo or a 1200-mg daily dose of zidovudine. Participants in the AIDS Clinical Trials Group protocol 019 were assigned to receive a placebo, a 500-mg daily dose of zidovudine, or a 1500-mg daily dose of zidovudine. Main Outcome Measure. - Progression to AIDS. Results. - The rates of progression to AIDS in subjects receiving zidovudine were significantly lower than those in subjects receiving a placebo among blacks (P=.03), whites (relative risk [RR] = 2.3, 95% confidence interval [CI] = 1.5 to 3.6, P<.0001), Hispanics (RR = 4.4, CI = 1.2 to 16.8, P=.02), non-Hispanics (RR = 2.3, CI = 1.5 to 3.6, P=.0002), men (RR = 2.5, CI = 1.6 to 3.8, P<.0001), and non-intravenous drug users (RR = 2.5, CI = 1.6 to 4.0, P<.0001). The rates of disease progression for subjects receiving zidovudine were not statistically different from those receiving placebo for women (RR = 3.3, CI = 0.3 to 36.3, P=.31) or for intravenous drug users (RR = 2.0, CI=0.7 to 6.2, P=.21); however, in both instances the estimated RRs were similar to those for men and nonintravenous drug users. Conclusions. - Although the two studies used for this analysis were not specifically designed to assess the effects of zidovudine in each separate subpopulation, the data suggest that the beneficial effects of zidovudine reported for the entire study population also apply to the subpopulations of blacks, Hispanics, women, and intravenous drug users.

Original languageEnglish
Pages (from-to)2709-2712
Number of pages4
JournalJournal of the American Medical Association
Volume266
Issue number19
StatePublished - Dec 1 1991

Fingerprint

Zidovudine
HIV Infections
Drug Users
Confidence Intervals
Clinical Protocols
Acquired Immunodeficiency Syndrome
Hispanic Americans
Placebos
Clinical Trials
Therapeutics
Virus Diseases
Disease Progression
Referral and Consultation
Outcome Assessment (Health Care)
HIV

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effects of zidovudine therapy in minority and other subpopulations with early HIV infection. / Lagakos, Stephen; Fischl, Margaret A; Stein, Daniel S.; Lim, Lynette; Volberding, Paul.

In: Journal of the American Medical Association, Vol. 266, No. 19, 01.12.1991, p. 2709-2712.

Research output: Contribution to journalArticle

Lagakos, Stephen ; Fischl, Margaret A ; Stein, Daniel S. ; Lim, Lynette ; Volberding, Paul. / Effects of zidovudine therapy in minority and other subpopulations with early HIV infection. In: Journal of the American Medical Association. 1991 ; Vol. 266, No. 19. pp. 2709-2712.
@article{c3b5097246da4d1791bf298020fb51ce,
title = "Effects of zidovudine therapy in minority and other subpopulations with early HIV infection",
abstract = "Objective. - The purpose of this study was to determine whether the beneficial effects of zidovudine seen overall in two recently completed placebocontrolled clinical trials are also apparent in blacks, Hispanics, women, and intravenous drug users. Design. - Two double-blind placebo-controlled randomized clinical trials, protocols 016 and 019, conducted by the AIDS Clinical Trials Group. Setting. - University-based referral centers. Participants. - Two thousand forty-eight persons with asymptomatic or mildly symptomatic human immunodeficiency virus infection were analyzed. Of these, 155 were black, 190 were Hispanic, 144 were women, and 221 were intravenous drug users. All randomized subjects were included in the analysis. Intervention. - Participants in the AIDS Clinical Trials Group protocol 016 were assigned to receive a placebo or a 1200-mg daily dose of zidovudine. Participants in the AIDS Clinical Trials Group protocol 019 were assigned to receive a placebo, a 500-mg daily dose of zidovudine, or a 1500-mg daily dose of zidovudine. Main Outcome Measure. - Progression to AIDS. Results. - The rates of progression to AIDS in subjects receiving zidovudine were significantly lower than those in subjects receiving a placebo among blacks (P=.03), whites (relative risk [RR] = 2.3, 95{\%} confidence interval [CI] = 1.5 to 3.6, P<.0001), Hispanics (RR = 4.4, CI = 1.2 to 16.8, P=.02), non-Hispanics (RR = 2.3, CI = 1.5 to 3.6, P=.0002), men (RR = 2.5, CI = 1.6 to 3.8, P<.0001), and non-intravenous drug users (RR = 2.5, CI = 1.6 to 4.0, P<.0001). The rates of disease progression for subjects receiving zidovudine were not statistically different from those receiving placebo for women (RR = 3.3, CI = 0.3 to 36.3, P=.31) or for intravenous drug users (RR = 2.0, CI=0.7 to 6.2, P=.21); however, in both instances the estimated RRs were similar to those for men and nonintravenous drug users. Conclusions. - Although the two studies used for this analysis were not specifically designed to assess the effects of zidovudine in each separate subpopulation, the data suggest that the beneficial effects of zidovudine reported for the entire study population also apply to the subpopulations of blacks, Hispanics, women, and intravenous drug users.",
author = "Stephen Lagakos and Fischl, {Margaret A} and Stein, {Daniel S.} and Lynette Lim and Paul Volberding",
year = "1991",
month = "12",
day = "1",
language = "English",
volume = "266",
pages = "2709--2712",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "19",

}

TY - JOUR

T1 - Effects of zidovudine therapy in minority and other subpopulations with early HIV infection

AU - Lagakos, Stephen

AU - Fischl, Margaret A

AU - Stein, Daniel S.

AU - Lim, Lynette

AU - Volberding, Paul

PY - 1991/12/1

Y1 - 1991/12/1

N2 - Objective. - The purpose of this study was to determine whether the beneficial effects of zidovudine seen overall in two recently completed placebocontrolled clinical trials are also apparent in blacks, Hispanics, women, and intravenous drug users. Design. - Two double-blind placebo-controlled randomized clinical trials, protocols 016 and 019, conducted by the AIDS Clinical Trials Group. Setting. - University-based referral centers. Participants. - Two thousand forty-eight persons with asymptomatic or mildly symptomatic human immunodeficiency virus infection were analyzed. Of these, 155 were black, 190 were Hispanic, 144 were women, and 221 were intravenous drug users. All randomized subjects were included in the analysis. Intervention. - Participants in the AIDS Clinical Trials Group protocol 016 were assigned to receive a placebo or a 1200-mg daily dose of zidovudine. Participants in the AIDS Clinical Trials Group protocol 019 were assigned to receive a placebo, a 500-mg daily dose of zidovudine, or a 1500-mg daily dose of zidovudine. Main Outcome Measure. - Progression to AIDS. Results. - The rates of progression to AIDS in subjects receiving zidovudine were significantly lower than those in subjects receiving a placebo among blacks (P=.03), whites (relative risk [RR] = 2.3, 95% confidence interval [CI] = 1.5 to 3.6, P<.0001), Hispanics (RR = 4.4, CI = 1.2 to 16.8, P=.02), non-Hispanics (RR = 2.3, CI = 1.5 to 3.6, P=.0002), men (RR = 2.5, CI = 1.6 to 3.8, P<.0001), and non-intravenous drug users (RR = 2.5, CI = 1.6 to 4.0, P<.0001). The rates of disease progression for subjects receiving zidovudine were not statistically different from those receiving placebo for women (RR = 3.3, CI = 0.3 to 36.3, P=.31) or for intravenous drug users (RR = 2.0, CI=0.7 to 6.2, P=.21); however, in both instances the estimated RRs were similar to those for men and nonintravenous drug users. Conclusions. - Although the two studies used for this analysis were not specifically designed to assess the effects of zidovudine in each separate subpopulation, the data suggest that the beneficial effects of zidovudine reported for the entire study population also apply to the subpopulations of blacks, Hispanics, women, and intravenous drug users.

AB - Objective. - The purpose of this study was to determine whether the beneficial effects of zidovudine seen overall in two recently completed placebocontrolled clinical trials are also apparent in blacks, Hispanics, women, and intravenous drug users. Design. - Two double-blind placebo-controlled randomized clinical trials, protocols 016 and 019, conducted by the AIDS Clinical Trials Group. Setting. - University-based referral centers. Participants. - Two thousand forty-eight persons with asymptomatic or mildly symptomatic human immunodeficiency virus infection were analyzed. Of these, 155 were black, 190 were Hispanic, 144 were women, and 221 were intravenous drug users. All randomized subjects were included in the analysis. Intervention. - Participants in the AIDS Clinical Trials Group protocol 016 were assigned to receive a placebo or a 1200-mg daily dose of zidovudine. Participants in the AIDS Clinical Trials Group protocol 019 were assigned to receive a placebo, a 500-mg daily dose of zidovudine, or a 1500-mg daily dose of zidovudine. Main Outcome Measure. - Progression to AIDS. Results. - The rates of progression to AIDS in subjects receiving zidovudine were significantly lower than those in subjects receiving a placebo among blacks (P=.03), whites (relative risk [RR] = 2.3, 95% confidence interval [CI] = 1.5 to 3.6, P<.0001), Hispanics (RR = 4.4, CI = 1.2 to 16.8, P=.02), non-Hispanics (RR = 2.3, CI = 1.5 to 3.6, P=.0002), men (RR = 2.5, CI = 1.6 to 3.8, P<.0001), and non-intravenous drug users (RR = 2.5, CI = 1.6 to 4.0, P<.0001). The rates of disease progression for subjects receiving zidovudine were not statistically different from those receiving placebo for women (RR = 3.3, CI = 0.3 to 36.3, P=.31) or for intravenous drug users (RR = 2.0, CI=0.7 to 6.2, P=.21); however, in both instances the estimated RRs were similar to those for men and nonintravenous drug users. Conclusions. - Although the two studies used for this analysis were not specifically designed to assess the effects of zidovudine in each separate subpopulation, the data suggest that the beneficial effects of zidovudine reported for the entire study population also apply to the subpopulations of blacks, Hispanics, women, and intravenous drug users.

UR - http://www.scopus.com/inward/record.url?scp=0025720779&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0025720779&partnerID=8YFLogxK

M3 - Article

C2 - 1942422

AN - SCOPUS:0025720779

VL - 266

SP - 2709

EP - 2712

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 19

ER -