Evaluation of Subcutaneous Proleukin (Interleukin-2) in a Randomized International Trial (ESPRIT): Geographical and Gender Differences in the Baseline Characteristics of Participants
| dc.contributor.author | ESPRIT Research Group | |
| dc.contributor.author | Pett | |
| dc.contributor.author | Wand | |
| dc.contributor.author | Law | |
| dc.contributor.author | Arduino | |
| dc.contributor.author | Lopez | |
| dc.contributor.author | Knysz | |
| dc.contributor.author | Pereira | |
| dc.contributor.author | Pollack | |
| dc.contributor.author | Reiss | |
| dc.contributor.author | Tambussi | |
| dc.date.accessioned | 2024-05-23T23:49:01Z | |
| dc.date.available | 2024-05-23T23:49:01Z | |
| dc.date.issued | 2006 | |
| dc.description | Fil: Pett. National Centre in HIV Epidemiology and Clinical Research University of New South Wales, Sydney; Australia | es_ES |
| dc.description.abstract | Background: ESPRIT, is a phase III, open-label, randomized, international clinical trial evaluating the effects of subcutaneous recombinant interleukin-2 (rIL-2) plus antiretroviral therapy (ART) versus ART alone on HIV-disease progression and death in HIV-1-infected individuals with CD4+ T-cells ≥300 cells/μL. Objectives: To describe the baseline characteristics of participants randomized to ESPRIT overall and by geographic location. Method: Baseline characteristics of randomized participants were summarized by region. Results: 4,150 patients were enrolled in ESPRIT from 254 sites in 25 countries. 41%, 27%, 16%, 11%, and 5% were enrolled in Europe, North America, South America, Asia, and Australia, respectively. The median age was 40 years, 81% were men, and 76%, 11%, and 9% were Caucasian, Asian, and African American or African, respectively. 44% of women enrolled (n = 769) were enrolled in Thailand and Argentina. Overall, 55% and 38% of the cohort acquired HIV through male homosexual and heterosexual contact, respectively. 25% had a prior history of AIDS-defining illness; Pneumocystis jirovecii pneumonia, M. tuberculosis, and esophageal candida were most commonly reported. Median nadir and baseline CD4+ T-cell counts were 199 and 458 cells/μL, respectively. 6% and 13% were hepatitis B or C virus coinfected, respectively. Median duration of antiretroviral therapy (ART) was 4.2 years; the longest median duration was in Australia (5.2 years) and the shortest was in Asia (2.3 years). 17%, 13%, and 69% of participants began ART before 1995, between 1996 and 1997, and from 1998 onward, respectively. 86% used ART from two or more ART classes, with 49% using a protease inhibitor-based regimen and 46% using a nonnucleoside reverse transcriptase inhibitor-based regimen. 78% had plasma HIV RNA below detection (<500 cp/mL). Conclusion: ESPRIT has enrolled a diverse population of HIV-infected individuals including large populations of women and patients of African-American/African and Asian ethnicity often underrepresented in HIV research. As a consequence, the results of the study may have wide global applicability. | es_ES |
| dc.format | application/pdf | es_ES |
| dc.identifier.doi | https://doi.org/10.1310/4733-ACQF-F3P4-2QAC | |
| dc.identifier.uri | https://repositorio.huesped.org.ar/handle/123456789/1298 | |
| dc.language | ENG | es_ES |
| dc.provenance | Published | es_ES |
| dc.relation.ispartofseries | HIV Clinical Trials;2006;7(2):70-85 | |
| dc.rights | openAccess | es_ES |
| dc.subject | Acquired Immunodeficiency Syndrome | es_ES |
| dc.subject | HIV | es_ES |
| dc.title | Evaluation of Subcutaneous Proleukin (Interleukin-2) in a Randomized International Trial (ESPRIT): Geographical and Gender Differences in the Baseline Characteristics of Participants | es_ES |
| dc.type | Articulo | es_ES |