[Congressional Record (Bound Edition), Volume 155 (2009), Part 19]
[Extensions of Remarks]
[Pages 25380-25381]
[From the U.S. Government Publishing Office, www.gpo.gov]




  RECOGNIZING TIBOTEC THERAPEUTICS FOR CONDUCTING THE GRACE STUDY, A 
GROUNDBREAKING HIV CLINICAL TRIAL FOCUSED ON WOMEN AND PEOPLE OF COLOR 
                          IN THE UNITED STATES

                                 ______
                                 

                        HON. CHARLES A. GONZALEZ

                                of texas

                    in the house of representatives

                      Wednesday, October 21, 2009

  Mr. GONZALEZ. Madam Speaker, I rise today to commend and congratulate 
Tibotec Therapeutics, part of the Johnson & Johnson family of 
companies, for demonstrating continued innovation and corporate 
responsibility in the fight against HIV/AIDS by conducting the 
groundbreaking GRACE study. GRACE, which stands for Gender Race And 
Clinical Experience, is the largest study to date in treatment-
experienced women with HIV to examine gender and race differences in 
response to an HIV therapy. Findings from this historic study were 
recently presented at the International AIDS Society conference in Cape 
Town, South Africa.
  In the United States, women are increasingly affected by HIV/AIDS, 
accounting for more than one quarter of all new HIV/AIDS diagnoses, 
with African American and Latina women representing seventy-nine 
percent of women living with the disease. People of color, both women 
and men, have been historically underrepresented in clinical trials in 
the United States, and HIV/AIDS disproportionately impacts our African 
American and Latino communities. In my home state of Texas, there are 
about 73,000 people living with AIDS, and Latinos represent almost one-
quarter of these cases. There are over 5,000 people living with HIV/
AIDS in San Antonio, and many more in the surrounding counties. In 
terms of new HIV infections, Latina women are infected at a rate almost 
four times as high as white women.

[[Page 25381]]

  Through innovative strategies, the GRACE study was able to enroll 
approximately seventy percent women, sixty percent African Americans 
and twenty-two percent Latinos. The trial was designed to help overcome 
some of the barriers which have historically deterred women and people 
of color from participating in clinical studies, including stigma, 
language and cultural barriers, and lack of child care, transportation, 
and personal support systems. Based upon advisor and community input, 
study participants could obtain assistance to cover costs associated 
with their participation in the study, including funds for travel and 
childcare, as well as food vouchers. I am very proud that one of the 
study sites in this historic clinical trial is located in my 
congressional district.
  Results of the GRACE study showed that there were no statistical 
differences in the safety, tolerability, or effectiveness of the HIV 
regimens used in the study between male and female participants, or for 
people of different ethnicities. Importantly, from my perspective, the 
GRACE study clearly showed that, with the appropriate commitment from 
the trial sponsor and input from affected communities and providers, 
clinical trials can, indeed, enroll meaningful numbers of women and 
racial and ethnic minorities.
  With the GRACE study, Tibotec Therapeutics and Johnson & Johnson 
continue to demonstrate their leadership and corporate social 
responsibility as innovators and leaders in the pharmaceutical 
industry. I commend them for their continuing commitment to the fight 
against HIV/AIDS and for their leadership in addressing the 
disproportionate impact of the HIV/AIDS epidemic on women and people of 
color.

                          ____________________