Differences in implementation of HIV/AIDS clinical research in developed versus developing world: An evidence-based review on protease inhibitor use among women and minorities

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Abstract

The aim of this revision is to evaluate ethnicity and gender rate of enrolment in registrative clinical trials of the protease inhibitors (Pls) from 1996 to 2009. Company-sponsored, phase II or III registrative clinical trials of PIs were evaluated. Forty-nine clinical trials were included. Clinical trials were conducted in centres in North America (n = 39), Central-South America (n = 22), Europe (n = 22), Africa (n = 8), Asia (n = 5), Australia (n = 10). Overall mean age was 39.6 years; median proportion of women was 16.3%. The most represented ethnic group was Caucasian. A test for trend over time (1996-2009) shows a significant increase in the proportion of women included (P = 0.012), and a decrease in the proportion of Caucasians included, reaching borderline significance (P = 0.061). An inverse correlation was observed between the proportion of Caucasians and that of women enrolled in each study (r = 20.65, P <0.0001). Women were less likely to be included in double-blind studies (11.2% versus 17%, P = 0.019). Clinical trials for treatment-naive subjects were more likely to enrol ethnicities other than Caucasian compared with Caucasian (44.7% versus 27.1%, respectively, P = 0.04). Rates of enrolment of minorities in registrative clinical trials for Pls show a positive trend since 1996, mirroring the growing number of people of different ethnic groups accessing ART.

Original languageEnglish
Pages (from-to)837-842
Number of pages6
JournalInternational Journal of STD and AIDS
Volume23
Issue number12
DOIs
Publication statusPublished - Dec 2012

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Protease Inhibitors
Acquired Immunodeficiency Syndrome
Clinical Trials
HIV
Research
Ethnic Groups
Central America
South America
North America
Double-Blind Method

Keywords

  • AIDS
  • Antiretroviral
  • Clinical trial
  • Ethnicity
  • Gender
  • HIV-infection
  • Pls
  • Protease inhibitors
  • Women

ASJC Scopus subject areas

  • Dermatology
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

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title = "Differences in implementation of HIV/AIDS clinical research in developed versus developing world: An evidence-based review on protease inhibitor use among women and minorities",
abstract = "The aim of this revision is to evaluate ethnicity and gender rate of enrolment in registrative clinical trials of the protease inhibitors (Pls) from 1996 to 2009. Company-sponsored, phase II or III registrative clinical trials of PIs were evaluated. Forty-nine clinical trials were included. Clinical trials were conducted in centres in North America (n = 39), Central-South America (n = 22), Europe (n = 22), Africa (n = 8), Asia (n = 5), Australia (n = 10). Overall mean age was 39.6 years; median proportion of women was 16.3{\%}. The most represented ethnic group was Caucasian. A test for trend over time (1996-2009) shows a significant increase in the proportion of women included (P = 0.012), and a decrease in the proportion of Caucasians included, reaching borderline significance (P = 0.061). An inverse correlation was observed between the proportion of Caucasians and that of women enrolled in each study (r = 20.65, P <0.0001). Women were less likely to be included in double-blind studies (11.2{\%} versus 17{\%}, P = 0.019). Clinical trials for treatment-naive subjects were more likely to enrol ethnicities other than Caucasian compared with Caucasian (44.7{\%} versus 27.1{\%}, respectively, P = 0.04). Rates of enrolment of minorities in registrative clinical trials for Pls show a positive trend since 1996, mirroring the growing number of people of different ethnic groups accessing ART.",
keywords = "AIDS, Antiretroviral, Clinical trial, Ethnicity, Gender, HIV-infection, Pls, Protease inhibitors, Women",
author = "Elena Seminari and {De Silvestri}, A. and L. Scudeller and V. Scotti and C. Tinelli",
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