L'ENTREVISTA

• Dra. Anna Bonjoch
• Metgessa.
• Treballa a la Fundació des de 1995.
• [llegir entrevista]

DESTACATS

RESEARCH

ONGOING STUDIES

MARAVIBOOST

Efficacy of treatment intensification with Maraviroc on HIV-1 viral latency in recently infected HIV-1 naïve patients starting Raltegravir plus Tenofovir/Emtricitabine.

TELE-VIH

Study to assess a new strategy to follow the patients based in the combination of presential conventional visits and visits by phone.

VIH-ZOL

Study to assess the effectiveness and safety of zoledronic acid to treat ostheoporosis in patients infected by HIV.

DISCOR-RAL

Pilot study to assess the role of immune activation and apoptosis as a marker for treatment intensification with Raltegravir in HIV-infected patients on antiretroviral therapy with long-term viral suppression and unfavourable immunologic response (Discordant patients: V+I-).

ITHACA

HIV-1 viral dynamics in subjects initiating Raltegravir therapy in Spain.

DRV 900100 QD

Pilot, opened, comparative and randomized study to assess the eficiency and safety of Darunavir/Ritonavir 900/100 mg once a day as a strategy for the simplifiction of the antiretroviral treatment.

TPVRTV_500100_IQ

Pilot clinical trial to assess the safety of reducing ritonavir doses in patients infected by the HIV having tipranavir/ritonavir 500/200 mg every 12 hours.

INTEGRAL

Impact of the intensification with raltegravir in the viral latence of HIV-1 in patients with a complete viral supression.

MORE

Pilot study to assess the effectiveness and safety over the first 12 weeks of high doses of ribavirine (1600 mg/day) with Epoietin support (450 IU/kg/week) in induction therapy in patients with hepatitis C coinfected by HIV who have not responded to previous therapies.

FIBROHIV

Pilot, open-label, randomised clinical trial to assess the effectiveness of duloxetine in fibromialgy treatment in patients infected by HIV 1+.

VIHCREC01

Study of a double strategy for the induction and expansion of the repertoire of T-cells based on the administration of growth hormone and vaccines in patients with HIV 1 infection.

PK-TRANSVERSAL

Cross-sectional study for the characterisation of the pharmacokinetic parameters of protease inhibitors and of non-nucleoside analogue reverse transcriptase inhibitors in the Spanish population of subjects infected by the HIV.

Observational Studies

FITO-TARV

Alternative therapies to antiretroviral treatment consumption by adult HIV-infected patients in our environment.

CE-GATES

Immunogenicity analyses of Conserved Elements (CE) in HIV.

CARDIOVASCULAR - HIV RISK

This study's goal is to identify HIV-infected patients liable to suffer a cardiovascular event to treat risky factors that can be modified.

Sub-study of cardiovascular risk. Inflammatory markers: Determinació de les característiques aterogèniques del perfil lipídic i marcadors d'inflamació i disfunció endotelial en pacients amb infecció pel virus d'immunodeficiència humana (VIH).

RENOVIH

Validation of Cockcroft-Gault (CG) formulas and Modification of diet in renal disease (MDRD) in HIV-1 infected population for the estimate of glomerular renal filtering.

OBS IQ

Pilot, observational study to assess the usefulness of the inhibitory quotient in patients infected by HIV receiving abtiretroviral treatment with protease inhibitors.

Apop-V+I-

Study of apopotosi role as a negative pathogenic mechanism of the immunologic response in patients having treatment with a constant viral supression (patients discordants V+ I-).

COHORT HPV WOMEN: FLS-HPV-2007-02 (WOMEN_PAPILOMA)

Cohorts study (women HIV-positives and HIV-negatives), prospective of the coexistance with infection by the human papiloma virus (HPV) in cervix, anus and oral cavity, and citological or histological lesions precursors of cancer.

COHORT HPV MEN: FLS-HPV-2007-01 (MEN_PAPILOMA)

Prospective study of the prevalence of infection by the human papiloma virus (HPV) in the oral cavity, penis and anus and of the incidence of anus cancer in HIV-positives men.

HIVACAT-SERONEG

HIV negatives cohort with risk of infection by the HIV.

Finished clinical trials (from 2006)

KANELA

Prospective, opened and randomized clinical trial, about the hepathic safety with antiretroviral treatments that include Kaletra vs Nevirapine in patients coinfected by HIV/VHC.

NEVIATAZ

Pilot clinical trial to assess the influence of nevirapine in exposure to atazanavir in adult patients infected by HIV in a stable balance condition.

startTDM-EFV

Pilot, open-label, parallel and randomised study to assess safety and therapeutic monitoring of plasma levels of efavirenz in HIV-infected patients initiating antiretroviral treatment with sustiva.

RALqd-ATV

Clinical trial assessing once daily Raltegravir administration (800 mg QD) in HIV-1 infected patients receiving unboosted Atazanavir (400 mg QD) - Based antiretroviral therapy.

SQV/rtvMONOTHERAPY

Pilot, open-label, comparative, randomised study to assess the effectiveness and safety of Saquinavir/Ritonavir in monotherapy vs Haart Therapy standard as maintenance therapy.

TETRIZ

Pilot, single-cenrte, open-label, randomised study to assess inmunovirological and clinical evolution of a combination with nucleoside/nucleotide analogues (trizivir + tenofovir) in multi-resistant patients with virological failure.

ELA

Multicentre, open-label, prospective, randomised clinical trial on an antiretroviral simplification treatment with efavirenz + abacavir + 3TC at a dose of once a day.

LAKE

Multicentre, open-label, prospective, randomised clinical trial to assess the effectiveness of abacavir 600 mg + lamivudine 300 mg at QD + efavirenz 600 mg QD versus kaletra 400/100 mg BID as an initial antiretroviral treatment.

CORAL-2

Open, multicentre and randomised phase IV study to evaluate the viral kinetics in the first 12 weeks of patients with chronic hepatitis C genotypes 1 and 4, coinfected by the human immune deficiency virus with an induction dose of Peginterferon alpha-2a (40 KD) (270 Ìg/week) amd Ribavirin (1600 mg/day) with Epoietin support (450 IU/kg/week).

MULTINEKA

Randomised, prospective, multicentre clinical trial on the effect of the combination of lopinavir/rtv + nevirapine as maintenance bitherapy (without nucleoside analogues) in comparison with triple therapy including lopinavir/rtv + nucleoside analogues in patients with HIV infection.

Finished observational studies (from 2006)

GELI

Genetic study to get information to identify people who, genetically, are liable to suffer lipid disorders due to antiretroviral treatment.

ELLIOT

Pilot, transversal study, to assess the impact of "observed stress" and "coherence sense" in immunologic answer and the presence of concomitant pathologies in patients infected by HIV-1.

AGING

Observational epidemiologic study to assess infection by HIV in patients over 70 years old.

SQV/VHC

Transverse study to assess the influence of coinfection by the Hepatitis C virus in exposure to saquinavir supported by ritonavir in patients infected by HIV.

KLAMORES

Simplified HAART (Kaletra in monotherapy) - a Retrospective Review (The KLAMORES study).

Centres participating in FLS studies:

Hospital de Granollers, Hospital " Joan XXIII" de Tarragona, Hospital Santa Creu i Sant Pau, Hospital del Mar, Hospital Arnau Vilanova (Lleida), Hospital Vall d'Hebron, Hospital Sant Joan de Reus, Hospital Provincial Santa Caterina (Girona), Hospital de Calella, Hospital de Mataró, Hospital General de Vic, Hospital Univ. de Bellvitge, Hospital Clínic Barcelona, Parc Taulí, Hospital Univ. Marqués de Valdecilla, Complejo Hosp. Univ. de Vigo "Xeral de Vigo", Hospital Universitario de Santiago, Hospital Arquitecto Marcide, Hospital Santa María Nai (Ourense), Hospital Cristal-Piñor (Ourense), Hospital do Meixoeiro, Hospital de Cruces (Baracaldo), Hospital Juan Canalejo (A Coruña), Hospital Central de Asturias, Hospital de Sierrallana de Torrelavega (Cantàbria), Hospital de Navarra, Hospital Virgen Macarena, Hosp. Univ. Virgen del Rocío, Hospital Costa del Sol, Hospital Clínic San Cecilio, Hospital Nuestra Sra. de Valme, Hospital Virgen de las Nieves, Hospital de Jerez de la Frontera, Hospital 12 de Octubre, Hospital Univ. de la Princesa, Hospital Univ. la Paz, Hospital Gregorio Marañón, Hospital Severo Ochoa (Leganés), Hospital Príncipe de Asturias, Hospital Clínic San Carlos, Hospital de Móstoles, Fundación Jiménez Díaz, Hospital Ramón y Cajal, Hospital Univ. de Getafe, Hospital Carlos III, Hospital La Fe, Hospital Clínic de València, Hospital Arnau de Vilanova (València), Hospital Gral. de Castelló, Hospital Gral. d'Alacant, Hospital Gral. Univ. d'Elx, Hospital Gral. Univ. de València, Hospital Univ. de Canarias, Hospital Univ. Ntra. Sra. de la Candelaria (Tenerife), Son Llàtzer (Balears), Hospital de Manacor, Hospital Gral. de Fuerteventura, Hospital Gral. de Lanzarote, Hospital Sta. María del Rosell (Múrcia), Hospital Gral. de Albacete, Hospital Ntra. Sra. del Prado (Talavera).

Studies monitored by FLS with external sponsors

These are studies where the Fundació provides its logistic support and experience in the management of clinical trials to sponsors from other hospitals.

EUROPA

Study of the changes in CD4 cell count following replacement of tenofovir by abacavir in patients with a HAART regimen including DDI + tenofovir and with viral suppression. Sponsor: Enric Pedrol, MD. Hospital de Granollers.

TRIMUNE

Pilot study on a restricted regimen in nucleoside analogue reverse transcriptase inhibitor for antiretroviral-naive HIV patients. Sponsor: Josep M Llibre, MD. Hospital Sant Jaume de Calella

NODy

Randomised, open-label, multicentre study comparing continuity with a HAART regimen comparing nevirapine twice-daily versus switching to once-daily in HIV infected patients. Sponsor: Daniel Podzamczer, MD. Hospital Universitari Bellvitge.

External Studies

In the course of 2007, the HIV Uniut and the Fundació participated in 48 studies with external sponsors (not specified due to confidentiality requirements).

These studies include clinical trials in all phases, observational studies and cohort studies.

Scholarships obtained

Eugènia Negredo, MD: Research worker of the grant "Characterization of protease executing cellular death inferred by HIV". FIPSE.

Main researcher: Julià Blanco

José Moltó, MD: "Development of a population pharmacokinetic model either for Lopinavir or Ritonavir in patients infected by the Human Inmunodeficiency Virus. Caixa Sabadell.

José Moltó, MD: Research worker of the grant "Development of population pharmacokinetic models of protease inhibitors reinforced by ritonavir. FIPSE.

Main researcher: Bonaventura Clotet

Validity period: 2005 – 2008