Some statistical issues in the design of HIV-1 vaccine and treatment trials

Statistical Methods in Medical Research

Volumn 9, Issue 3, 2000, Pages 207-229

  Gilbert, P B ^a  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

CLINICAL TRIAL; DRUG EFFECT; DRUG EFFICACY; FACTORIAL ANALYSIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LATIN SQUARE DESIGN; MEDICAL RESEARCH; NONHUMAN; RETROVIRUS; RETROVIRUS INFECTION; REVIEW; STATISTICAL ANALYSIS; VACCINATION;

EID: 0033777031     PISSN: 09622802     EISSN: None     Source Type: Journal    
DOI: 10.1177/096228020000900303     Document Type: Review

References (64)

1. The role of US government agencies in vaccine research and development
2. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents
3. AIDS trials ethics questioned
4. Nonparametric inference for a family of counting processes
5. Estimating disease attack rates in heterogeneous interacting populations, with applications to HIV vaccine trials
6. Intention to treat in clinical trials
7. Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines - Report of the national multicenter trial
8. Randomized placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis
9. Efficacy in infancy of oligosaccharide conjugate Haemophilus influnzae type b (HbOC) vaccine in a United States population of 61,080 children
10. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine
11. A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children
12. The prevention of hepatitis B with vaccine. Report of the centers for disease control multicenter efficacy trial among homosexual men
13. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group
14. Statistical issues in the design of HIV vaccine trials
15. A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): A final report
16. Assessment of the protective efficacy of vaccines against common diseases using case-control and cohort studies
17. Interpretation and estimation of vaccine efficacy under heterogeneity
18. Partial residuals for the proportional hazards regression model
19. Proportional hazards tests and diagnostics based on weighted residuals
20. Estimation of vaccine efficacy in the presence of waning: Application to cholera vaccines
21. Surrogate endpoints in clinical trials: Definition and operational criteria
22. Surrogate endpoints in clinical trials: Are we being misled?
23. Evaluation of active control trials in AIDS
24. Evaluating therapeutic interventions
25. On the analysis of viral load endpoints in HIV vaccine trials
26. Measuring vaccine efficacy for both susceptibility to infection and reduction in infectiousness for prophylactic HIV-1 vaccines
27. Randomization by cluster: Sample size requirements and analysis
28. Study designs for evaluating different efficacy and effectiveness aspects of vaccines
29. Study designs for dependent happenings
30. Design of human immunodeficiency virus intervention trials in developing countries
31. Lessons for AIDS vaccine development from non-AIDS vaccines
32. Immunization against virus disease
33. Antiretroviral therapy for HIV infection in 1998: Updated recommendations of the International AIDS Society-USA Panel
34. Genetic and immunologic characterization of viruses infecting MN-rgp120-vaccinated volunteers
35. Statistical methods for assessing differential vaccine protection against human immunodeficiency virus types
36. Immunological and virological analyses of persons infected by human immunodeficiency virus type 1 while participating in trials of recombinant gp120 subunit vaccines
37. Maximum likelihood estimation in semiparametric selection bias models with application to AIDS vaccine trials
38. Comparison of competing risks failure time methods and time-independent methods for assessing strain variations in vaccine protection
39. Interpretability and robustness of sieve analysis models for assessing HIV strain variations in vaccine efficacy
40. Separate sample logistic discrimination
41. The analysis of failure time in the presence of competing risks
42. Applying Cox regression to competing risks
43. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment
44. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial
45. International multicentre pooled analysis of late postnatal mother-to-child transmission of HIV-1 infection. Ghent International Working Group on Mother-to-Child Transmission of HIV
46. Advancing AIDSVAX to phase 3: Safety, immunogenicity, and plans for phase 3
47. Design of clinical trials: Endpoints. Consideration in the selection of endpoints for AIDS clinical trials
48. Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in HIV clinical trials
49. + lymphocytes are an incomplete surrogate marker for clinical progression in persons with asymptomatic HIV infection taking zidovudine
50. + lymphocytes in patients with AIDS and AIDS-related complex
51. Surrogate markers in AIDS and cancer trials
52. CD4 cell count as a surrogate endpoint in HIV clinical trials: A meta-analysis of studies of the AIDS Clinical Trials Group
53. Statistical properties of randomization in clinical trials
54. Adjusting for nonignorable drop-out using semiparametric nonresponse models
55. The efficiency of the proportions test and the logrank test for censored survival data
56. Applicability of sample size calculations based on a comparison of proportions for use with the logrank test
57. A statistical method giving early and unbiased conclusions from clinical trials
58. Efficient trial designs for studying combination antiretroviral treatments in patients with various resistance profiles