Online citations, reference lists, and bibliographies.
← Back to Search

A Trial Comparing Nucleoside Monotherapy With Combination Therapy In HIV-infected Adults With CD4 Cell Counts From 200 To 500 Per Cubic Millimeter. AIDS Clinical Trials Group Study 175 Study Team.

S. Hammer, D. Katzenstein, M. Hughes, H. Gundacker, R. Schooley, R. Haubrich, W. K. Henry, M. Lederman, J. Phair, M. Niu, M. Hirsch, T. Merigan
Published 1996 · Medicine

Save to my Library
Download PDF
Analyze on Scholarcy Visualize in Litmaps
Reduce the time it takes to create your bibliography by a factor of 10 by using the world’s favourite reference manager
Time to take this seriously.
Get Citationsy
BACKGROUND This double-blind study evaluated treatment with either a single nucleoside or two nucleosides in adults infected with human immunodeficiency virus type 1 (HIV-1) whose CD4 cell counts were from 200 to 500 per cubic millimeter. METHODS We randomly assigned 2467 HIV-1--infected patients (43 percent without prior antiretroviral treatment) to one of four daily regimens: 600 mg of zidovudine; 600 mg of zidovudine plus 400 mg of didanosine; 600 mg of zidovudine plus 2.25 mg of zalcitabine; or 400 mg of didanosine. The primary end point was a > or = 50 percent decline in the CD4 cell count, development of the acquired immunodeficiency syndrome (AIDS), or death. RESULTS Progression to the primary end point was more frequent with zidovudine alone (32 percent) than with zidovudine plus didanosine (18 percent; relative hazard ratio, 0.50; P<0.001), zidovudine plus zalcitabine (20 percent; relative hazard ratio, 0.54; P<0.001), or didanosine alone (22 percent; relative hazard ratio, 0.61; P<0.001). The relative hazard ratios for progression to an AIDS-defining event or death were 0.64 (P=0.005) for zidovudine plus didanosine, as compared with zidovudine alone, 0.77 (P=0.085) for zidovudine plus zalcitabine, and 0.69 (P=0.019) for didanosine alone. The relative hazard ratios for death were 0.55 (P=0.008), 0.71 (P=0.10), and 0.51 (P=0.003), respectively. For zidovudine plus zalcitabine, the benefits were limited to those without previous treatment. CONCLUSIONS Treatment with zidovudine plus didanosine, zidovudine plus zalcitabine, or didanosine alone slows the progression of HIV disease and is superior to treatment with zidovudine alone. Antiretroviral therapy can improve survival in patients with 200 to 500 CD4 cells per cubic millimeter.
This paper references
A multiple testing procedure for clinical trials.
P. C. O'brien (1979)
The Statistical Analysis of Failure Time Data.
M. Aitkin (1981)
Clinical Trials: A Practical Approach
S. Pocock (1984)
The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. A double-blind, placebo-controlled trial.
M. Fischl (1987)
The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection a double-blind, placebo-controlled trial
M. Fischl (1990)
Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. The AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases.
P. Volberding (1990)
Combination therapy with zidovudine and dideoxycytidine in patients with advanced human immunodeficiency virus infection. A phase I/II study.
T. Meng (1992)
A controlled trial of early versus late treatment with zidovudine in symptomatic human immunodeficiency virus infection. Results of the Veterans Affairs Cooperative Study.
J. Hamilton (1992)
Stopping guidelines for clinical trials with multiple treatments.
M. Hughes (1993)
Zidovudine in persons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter. The European-Australian Collaborative Group.
D. Cooper (1993)
Combination Therapy with Zidovudine and Didanosine Compared with Zidovudine Alone in HIV-1 Infection
A. Collier (1993)
Concorde: MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection
Ann Marie Swart (1994)
A randomized pilot study of alternating or simultaneous zidovudine and didanosine therapy in patients with symptomatic human immunodeficiency virus infection.
R. Yarchoan (1994)
Combination therapy for infection due to human immunodeficiency virus type 1.
A. Caliendo (1994)
Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infection
D. Ho (1995)
Viral dynamics in human immunodeficiency virus type 1 infection
X. Wei (1995)
In vivo emergence of HIV-1 variants resistant to multiple protease inhibitors
J. Condra (1995)
Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy.
B. Larder (1995)
A preliminary study of ritonavir, an inhibitor of HIV-1 protease, to treat HIV-1 infection.
M. Markowitz (1995)
Safety and activity of saquinavir in HIV infection
V. Kitchen (1995)
Treatment with lamivudine, zidovudine, or both in HIV-positive patients with 200 to 500 CD4+ cells per cubic millimeter. North American HIV Working Party.
J. Eron (1995)
A comparison of immediate with deferred zidovudine therapy for asymptomatic HIV-infected adults with CD4 cell counts of 500 or more per cubic millimeter. AIDS Clinical Trials Group.
P. Volberding (1995)
Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine. AIDS Clinical Trials Group.
R. Dolin (1995)
A short-term study of the safety, pharmacokinetics, and efficacy of ritonavir, an inhibitor of HIV-1 protease. European-Australian Collaborative Ritonavir Study Group.
S. Danner (1995)
Combination and Monotherapy with Zidovudine and Zalcitabine in Patients with Advanced HIV Disease
M. Fischl (1995)
Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS.
L. Saravolatz (1996)
Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. AIDS Clinical Trials Group.
A. Collier (1996)
Delta: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals
J. Darbyshire (1996)
Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine-experienced patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group.
S. Staszewski (1996)
Nevirapine, Zidovudine, and Didanosine Compared with Zidovudine and Didanosine in Patients with HIV-1 Infection
R. D'Aquila (1996)
Lamivudine Plus Zidovudine Compared with Zalcitabine Plus Zidovudine in Patients with HIV Infection
J. Bartlett (1996)
The Effect of High-Dose Saquinavir on Viral Load and CD4+ T-Cell Counts in HIV-Infected Patients
J. Schapiro (1996)

This paper is referenced by
SMIM: A unified framework of Survival sensitivity analysis using Multiple Imputation and Martingale.
S. Yang (2021)
Attacking COVID-19 Progression Using Multi-Drug Therapy for Synergetic Target Engagement
Mathew A Coban (2021)
Robust index of confidence weighted learning for optimal individualized treatment rule estimation
Jinchun Zhang (2021)
Semiparametric counterfactual density estimation
Edward H. Kennedy (2021)
Learning Optimal Distributionally Robust Individualized Treatment Rules
Weibin Mo (2021)
Maximum profile binomial likelihood estimation for the semiparametric Box--Cox power transformation model
Pengfei Li (2021)
Bing Chen (2021)
Estimation and visualization of treatment effects for multiple outcomes
Shintaro Yuki (2021)
An Efficient Multiple Imputation Approach for Estimating Equations with Response Missing at Random and High-Dimensional Covariates
L. Wang (2021)
Estimating average treatment effect on the treated via sufficient dimension reduction
Lu Li (2021)
Estimation and hypothesis testing with error‐contaminated survival data under possibly misspecified measurement error models
G. Yi (2021)
Enabling counterfactual survival analysis with balanced representations
Paidamoyo Chapfuwa (2021)
Dimension-reduced semiparametric estimation of distribution functions and quantiles with nonignorable nonresponse
L. Wang (2021)
GEAR: On Optimal Decision Making with Auxiliary Data
Hengrui Cai (2021)
A beyond multiple robust approach for missing response problem
Qihua Wang (2021)
Estimation for frailty measurement error Cox models based on profile likelihood and Bayes methods
Caiya Zhang (2021)
Human TRIM5α: Autophagy Connects Cell-Intrinsic HIV-1 Restriction and Innate Immune Sensor Functioning
A. Cloherty (2021)
A Convex Programming Solution Based Debiased Estimator for Quantile with Missing Response and High-dimensional Covariables
Miaomiao Su (2020)
Semiparametric estimation of copula models with nonignorable missing data
Feng Guo (2020)
Quantile-Based Subgroup Identification for Randomized Clinical Trials
Youngjoo Cho (2020)
Smoothed empirical likelihood inference and variable selection for quantile regression with nonignorable missing response
T. Zhang (2020)
A projection-based model checking for heterogeneous treatment effect
Niwen Zhou (2020)
Effects of Proportional Hazard Assumption on Variable Selection Methods for Censored Data
Alvin Sheng (2020)
Estimating Individual Treatment Effects using Non-Parametric Regression Models: a Review
Alberto Caron (2020)
Empirical Likelihood-Based Estimation and Inference in Randomized Controlled Trials with High-Dimensional Covariates.
W. Liang (2020)
Empirical Likelihood Inference in Randomized Controlled Trials with High-Dimensional Covariates
W. Liang (2020)
30 Jahre ART: Vom Todesurteil zur chronischen Erkrankung
Julian Hafner (2020)
Multicategory Angle-based Learning for Estimating Optimal Dynamic Treatment Regimes with Censored Data
Fei Xue (2020)
Jackknife empirical likelihood for the error variance in linear errors-in-variables models with missing data
Hong-Xia Xu (2020)
Nearly Dimension-Independent Sparse Linear Bandit over Small Action Spaces via Best Subset Selection
Yining Wang (2020)
LPRE criterion based estimating equation approaches for the error-in-covariables multiplicative regression models
Q. Wang (2020)
See more
Semantic Scholar Logo Some data provided by SemanticScholar