Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial (ESPRIT): geographical and gender differences in the baseline characteristics of participants.
HIV Clin Trials
; 7(2): 70-85, 2006.
Article
in En
| MEDLINE
| ID: mdl-16798622
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 > or =300 cells/microL.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/muL, 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.
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Collection:
01-internacional
Health context:
2_ODS3
/
3_ND
/
4_TD
/
6_ODS3_enfermedades_notrasmisibles
Database:
MEDLINE
Main subject:
HIV Infections
/
Randomized Controlled Trials as Topic
/
Data Collection
/
HIV-1
/
Interleukin-2
/
Anti-HIV Agents
Type of study:
Clinical_trials
Aspects:
Determinantes_sociais_saude
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
En
Journal:
HIV Clin Trials
Year:
2006
Document type:
Article