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Bonaventura Clotet Sala (Barcelona, 1953) is a Spanish physician. [1] He has been the head of the HIV unit at the Germans Trias i Pujol University Hospital (HUGTiP) in Badalona from 1987 to 2015, and since then he has been the head of the Infectious Diseases service at the same hospital. He has been the director of the IrsiCaixa AIDS Research ...
Dr Bonaventura Clotet was awarded his MD in 1976 and his PhD on autoimmune diseases in 1981 by the Autonomous University of Barcelona (UAB). His internship as an Internal Medicine specialist at the Vall d’Hebron University Hospital in Barcelona coincided with the first AIDS case reported in Spain. That case was the catalyst for a career ...
Dr. Clotet is also the Director of the retrovirology laboratory at “IrsiCaixa” Foundation and professor of the “Chair of AIDS and related diseases” at the Universitat de VIC (UVic-UCC). He was Head of the HIV Unit of the Hospital Germans Trias between 1987 and 2015, when he became Head of the Infectious Diseases Department. He is also ...
Bonaventura Clotet, born in Barcelona in 1953, holds a PhD in Medicine from the Autonomous University of Barcelona.He is President of the Fundació Lluita contra les Infeccions, Director of the AIDS Research Institute (IrsiCaixa) and territorial director on Infectious Diseases in the management of the Northern Metropolitan Area of the Catalan Institute of Health (ICS).
- Abstract
- Methods
- Results
- Discussion
- Notes
Integrase inhibitors (INIs) represent a class of drugs for the treatment of human immunodeficiency virus (HIV)–infected individuals, blocking HIV genome integration into the host cell DNA . They have been shown to be highly effective for the treatment of antiretroviral-naive and antiretroviral-experienced subjects, as demonstrated first with ralteg...
Study Design
VIKING (ING112961) is a phase IIb, multicenter, open-label, single-arm, pilot study with 2 sequential cohorts of HIV-1–infected individuals with current or historic RAL treatment failure and evidence of RAL resistance at screening. The 50-mg once-daily dose of DTG was initially selected for evaluation (cohort I); however, the viral load response of some subjects prompted protocol amendment and subsequent evaluation of DTG 50 mg as a twice-daily regimen (cohort II). For inclusion in cohort I,...
Subjects
Antiretroviral therapy (ART)–experienced, HIV-1–infected adults (≥18 years of age) with plasma HIV-1 RNA levels of ≥1000 copies/mL, genotypic INI resistance, and documented genotypic and/or phenotypic resistance to ≥1 compound in each of 2 other approved classes of ART (nucleoside reverse transcriptase inhibitors [NRTIs], nonnucleoside reverse transcriptase inhibitors [NNRTIs], protease inhibitors [PIs], and fusion/entry inhibitors) were eligible for enrollment. The availability of ≥1 fully a...
Efficacy Assessments
The primary efficacy end point was the proportion of subjects on day 11 with a plasma HIV-1 RNA load of <400 copies/mL or of ≥0.7 log10 copies/mL below the baseline value, as quantified by the Abbott RealTime HIV-1 amplification assay (Abbott Molecular, Des Plaines, IL). Secondary efficacy end points included at day 11 and subsequent visits were as follows: mean change from baseline in plasma HIV-1 RNA level; proportion of subjects with plasma HIV-1 RNA loads of <400 and <50 copies/mL, on the...
Demographic and Baseline Characteristics
Of 53 and 54 subjects screened for cohorts I and II, respectively, 27 and 24 subjects were enrolled to compose the intent-to-treat exposed populations. Demographic and baseline characteristics generally were similar for the 2 cohorts (Table 1). Subjects were predominantly white men, with a median age of 48 years. Twenty-six percent and 29% of the subjects in cohorts I and II, respectively, had advanced HIV disease, defined on the basis of a CD4+ T-cell count of <50 cells/mm3. Both cohorts had...
Efficacy
Ninety-six percent of subjects (23 of 24) in cohort II and 78% of subjects (21 of 27) in cohort I achieved the primary end point (ie, a reduction in plasma HIV-1 RNA level of ≥0.7 log10 copies/mL below the baseline value or a level of <400 copies/mL at day 11; Table 2). Thirteen subjects (54%) in cohort II and 11 subjects (41%) in cohort I achieved an HIV-1 RNA level of <400 copies/mL on day 11. The respective numbers for subjects with HIV-1 RNA levels of <50 copies/mL were 4 (17%) and 3 (11%...
Safety
The safety profile of DTG was similar in both cohorts. Adverse events (grade ≥2) were reported by 13 subjects (48%) and 16 subjects (67%) in cohorts I and II, respectively (Table 3), but no obvious trend in increased reporting of any individual parameter was observed in cohort II. Serious AEs were reported in 4 and 3 subjects in cohorts I and II, respectively; none of these were considered related to DTG treatment, and no specific serious AE was reported by >1 subject. Two deaths were reporte...
VIKING is the first study to explore DTG treatment of HIV-1–infected subjects who had experienced virologic failure during receipt of a RAL-containing regimen and had genotypic evidence of RAL resistance. Despite the presence of HIV-1 with a very high level of resistance to RAL, a rapid antiviral response was observed in both cohorts, with a better...
Acknowledgments.We thank Pratibha Hebbar and Chris Lawrence, for their editorial assistance during the development of this manuscript; and the study site staff and the study participants and their families and caregivers, for participation in the trial. In addition to the authors, the VIKING investigators included: Canada: Sharon L. Walmsley and Jo...
- Joseph J. Eron, Bonaventura Clotet, Jacques Durant, Christine Katlama, Princy Kumar, Adriano Lazzari...
- 2013
Director irsiCaixa AIDS Research Institute - Cited by 63,451
Dr. Clotet received his doctorate in Medicine from the Autonomous University of Barcelona (UAB), with a thesis on autoimmune diseases. Currently he is the head of the Infectious Diseases Service of the Hospital Universitari Germans Trias i Pujol, president of the Fight AIDS and Infectious Diseases Foundation, director of the Institute of AIDS Research IrsiCaixa, and co-director of the HIVACAT ...
