OBJECTIVE:To gather qualitative data regarding HIV/AIDS patients' perspectives about HIV-1 protease inhibitors (PIs), and about their experiences taking and adhering to regimens containing PIs. DESIGN:Six focus groups of persons under care for HIV were conducted between September and November 1996 regarding participants' knowledge, awareness, experiences when taking, and adherence to antiretroviral regimens containing PIs. An identical discussion guide was used to facilitate all six groups. Focus group proceedings were audiotaped, transcribed, coded for themes, and analyzed qualitatively. SETTING: HIV/AIDS practices of three teaching hospitals and two community health centers. PATIENTS/PARTICIPANTS:Fifty-six patients with HIV disease: 28 men and 28 women. MEASUREMENTS AND MAIN RESULTS:Knowledge and positive impressions of PIs were prevalent among this diverse group of persons with HIV, and did not differ by race/ethnicity or gender. Most knew that these were new, potent medications for treating HIV/AIDS. Networks of persons with HIV and medical providers were the most important information sources. Those taking PIs were aware that adherence to the regimen is important, and most were using special strategies to maximize their own adherence, but expressed considerable frustration about the central role these medication regimens had assumed in their life. A subset who did not believe they would adhere to these regimens had declined treatment with them. Motivating factors for taking and adhering to these complex regimens were improving CD4 counts and viral loads and the patient-provider relationship. CONCLUSIONS:Among those with HIV/AIDS, awareness of PIs and their effectiveness is substantial, owing to the impact of informal networks and medical providers. This early positive "reputation" of PIs may enhance motivation for adherence. Those who are taking PIs invest substantial effort adhering to these complex regimens, but resent the need to make medications the focus of their lives.
We assessed the effect of influenza vaccination on plasma levels of human immunodeficiency virus type 1 (HIV-1) RNA and the impact of age, plasma HIV-1 RNA level, CD4 cell count, and anti-HIV therapy on immune response. Forty-nine adults (mean age, 38.7 years; mean CD4 cell count +/- SD, 190 +/- 169/mL; mean plasma HIV-1 RNA level +/- SD, 154,616 +/- 317,192 copies/mL) were immunized. Elevations of > or = 0.48 log in plasma HIV-1 RNA levels occurred in two (4%) of 49 subjects within 4 weeks of vaccination. A fourfold or greater increase in antibody titer occurred in 13 (45%) of 29 subjects, correlating directly with CD4 cell count (P = .002) and inversely with plasma HIV-1 RNA level (P = .034). By multivariate analysis, CD4 cell count was a stronger predictor of antibody response than was plasma HIV-1 RNA level. We conclude that increases in plasma HIV-1 RNA levels following influenza vaccination are rare and transient and that antibody response is impaired with CD4 cell counts of < 100/mL and plasma HIV-1 RNA levels of > 100,000 copies/mL. Prospective trials are needed to evaluate the impact of highly active therapy on immune response after vaccination.
OBJECTIVES:To determine whether participation rates of women, persons of color, and injection drug users in AIDS clinical trials are similar to those of other HIV/AIDS patients, and to examine whether differences in patients' knowledge of clinical trials or reasons for not participating explain differences in participation rates by gender, race, or drug use. DESIGN: HIV infection and AIDS 1 are having an increasing impact on mortality and quality of life for women and persons of color in the United States. [2][3][4] In 1995, the AIDS incidence rate among blacks and Latinos was more than six times and two times, respectively, the rate among whites in the United States. 4 The incidence of AIDS is also increasing more rapidly among women than men; AIDS is now the third leading cause of death for all U.S. women aged 25 to 44 years. 2,5 This disease is increasingly afflicting women from all U.S. communities, but there has been a disproportionate increase in the prevalence of AIDS among minority women, particularly African Americans, Latinas, and Caribbean blacks. Women from communities of color together have accounted for nearly 76% of all reported cases of AIDS in women, while these groups represent only 21% of the general population of U.S. women. 2,5 And notably, the most common route of HIV acquisition among both women and persons of color diagnosed with AIDS to date has been injection drug use. 5 Despite their growing representation among AIDS cases, women, racial or ethnic minorities, and injection drug users have generally been underrepresented in clinical trials of drugs for the treatment of AIDS and early HIV disease. 6-10 To date, most clinical trials of treatment for HIV and HIV-related complications have been composed primarily of homosexual white men, with low participation of women, persons of color, and injection drug users. [6][7][8][9][10] Failure to include adequate numbers of women and persons of color may limit the generalizability and usefulness of study results for clinical practice. Furthermore, these subpopulations of HIV-infected individuals-women, persons of color, and injection drug users-have not had the benefit of early access to new treatments and prophylaxis for HIV and its complications that clinical trials have provided for participants. [6][7][8][9][10][11][12] It has been hypothesized that the lower participation of women, persons of color, and drug users primarily reflects impaired access to trials, due to several factors. Most initial AIDS Clinical Trials Units (ACTUs) were in centers that cared for few minorities, women, or drug users with HIV 8-10 ; and until recently, AIDS clinical trials have had restrictive eligibility criteria for women and injection drug users. 11,[13][14][15] Finally, minority patients, especially African Americans, may avoid participation in clinical trials because of suspicions about medical research resulting from a legacy of past studies that misused subjects. 8,10,16,17 Currently, there is little information about the relative rates of participation ...
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