Browsing by Author "Podzamczer, Daniel"

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    A Randomized Clinical Trial Comparing Nelfinavir Or Nevirapine Associated to Zidovudine/Lamivudine in HIV-Infected Naive Patients (The Combine Study)
    (2002-07) Podzamczer, Daniel; Ferrer, Elena; Consiglio, Ezequiel; Mariá Gatell, José; Perez, Pepa; Perez, José Luis; Luna, Elena; González, Alicia; Pedrol, Enric; Lozano, Luisa; Ocaña, Imma; Llibre, Josep María; Casiró, Arnaldo; Aranda, Miquel; Barrufet, Pilar; Martínez-Lacasa, Javier; Miró, José María; Badía, Xavier; Casado, Alfonso; Lupo, Sergio; Cahn, Pedro; Maños, Manel; Estela, Jordi; The Combine Study Team (Members Listed In Appendix)
    Background Non-nucleoside reverse transcriptase inhibitor-containing regimens may be a valid alternative to protease inhibitor-containing regimens for initial antiretroviral therapy, but to date few studies comparing these two strategies have been performed. Objective To evaluate the efficacy and safety of nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV-infected naive patients. Design Randomized, open-label, multicentre trial. Setting Twelve centres in Spain (9) and Argentina (3). Patients One hundred and forty-two HIV-infected naive patients without AIDS. Interventions Patients received combivir (zidovudine 300 mg/lamivudine 150 mg, twice-daily) plus either nelfinavir (1250 mg) twice-daily (zidovudine/lamivudine/nelfinavir, n=70) or nevirapine (200 mg) twice-daily (zidovudine/lamivudine/nevirapine, n=72), and were followed for 12 months. The primary endpoint was the proportion of patients with a plasma HIV-1 RNA (pVL) of less than 200 copies/ml by PCR at 12 months. pVL of less than 20 copies/ml (PCR), changes in CD4 counts, clinical progression and adverse events were also evaluated. Efficacy was assessed using intent-to-treat (ITT) (missing=failure) and on-treatment analysis. Results At 12 months in the ITT analysis the proportion of patients with pVL below 200 copies/ml was 60% (95% CI 48.5–71.5) in the zidovudine/lamivudine/nelfinavir arm and 75% (95% CI 65–85) in the zidovudine/lamivudine/nevirapine arm (P=0.06), and the proportion below 20 copies/ml was 50% (95% CI 38.3–61.7) and 65% (95% CI 54.2–76.2), respectively (P=0.06). No differences were found when comparing the subgroup of patients with baseline pVL of more than 100 000 copies/ml. A gain of +173 and +162 CD4 cells/mm3, respectively, was observed. Zidovudine/lamivudine/nelfinavir was discontinued in 21% of patients, and zidovudine/lamivudine/ nevirapine in 25%, due to toxicity (P>0.2). Conclusions Our results suggest that zidovudine/ lamivudine/nevirapine is at least as effective as zidovudine/lamivudine/nelfinavir as first-line therapy for HIV disease.
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    Características clinicoepidemiológicas y tendencias en el tratamiento antirretroviral de una cohorte de pacientes con infección por el virus de la inmunodeficiencia humana. Cohorte PISCIS
    (2005-04) Jaén, Ángeles; Casabona, Jordi; Esteve, Anna; Miró, Jose M; Tural, Cristina; Ferrer, Elena; Riera, Melchor; Segura, Ferran; Force, Lluís; Sued, Omar; Vilaró, Josep; Masabeu, Àngels; García, Isabel; Dorca, Esther; Altès, Jordi; Navarro, Gemma; Podzamczer, Daniel; Villalonga, Concepción; Clotet, Bonaventura; Gatell, Jose
    Fundamento y objetivo: Los objetivos de este estudio fueron describir el proceso de implementación de la cohorte PISCIS y las características clinicoepidemiológicas y las tendencias en el tratamiento antirretroviral (TARV) de los pacientes con infección por el virus de la inmunodeficiencia humana (VIH) incluidos desde 1998 hasta 2003. Pacientes y método: Estudio de cohorte prospectivo de pacientes con infección por el VIH de 16 años de edad o mayores atendidos en primera visita en 10 hospitales de Cataluña y uno de las Baleares. El análisis estadístico de las tendencias se realizó mediante el test de la *2 de Mantel. Resultados: Se incluyó a un total de 5.968 pacientes (edad media: 39,5 años; 75% varones) con un tiempo medio de seguimiento de 26,4 meses (13.130 personas-año). Del total, 2.763 fueron nuevos diagnósticos, en los que la vía de transmisión más frecuente fue la heterosexual (43%), seguida de la homosexual (31%). Se observó una tendencia significativamente creciente en la proporción de sujetos de edad inferior a 35 años e inmigrantes. Un 43% tenían una cifra de linfocitos CD4 inferior a 200 células/µl en la determinación más cercana al diagnóstico de la infección por el VIH. Del total, un 87% estaban en TARV en el año 2003. Entre los pacientes no tratados previamente que iniciaron pautas de TARV con 3 o más fármacos, se observó una disminución de las pautas que incluían inhibidores de la proteasa (del 85% en 1998 al 25% en 2003; p < 0,001), mientras que aumentaron otras que contenían inhibidores de la transcriptasa inversa no análogos y análogos de los nucleósidos. Conclusiones: Las cohortes de pacientes con infección por el VIH son viables en nuestro medio y tienen gran utilidad clínica y en salud pública. La vía de transmisión más frecuente entre los nuevos diagnósticos es la heterosexual, el retraso en el diagnóstico es elevado y las pautas de TARV han ido cambiando para adaptarse a las recomendadas por las guías.
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    Continued indinavir versus switching to indinavir/ritonavir in HIV-infected patients with suppressed viral load
    (2003-04-11) Arnaiz, Juan A; Mallolas, Josep; Podzamczer, Daniel; Gerstoft, Jan; Lundgren, Jens D; Cahn, Pedro; Fätkenheuer, Gerd; D'Arminio-Monforte, Antonella; Casiró, Arnaldo; Reiss, Peter; Burger, David M; Stek, Michael; Gatell, Jose
    Objective: To compare continued indinavir (IDV) 8-hourly (q8h) with switching to indinavir/ritonavir (IDV/RTV) 12-hourly (q12h) in HIV-positive patients having suppressed viral load with IDV q8h plus two nucleoside reverse transcriptase inhibitors (NRTI). Design: Multicentre, international, randomized, open-label study enrolling HIV-1 infected patients on IDV 800 mg q8h plus two NRTI with CD4 cell counts > or = 100 x 106/l and plasma HIV RNA < 500 copies/ml for > or = 3 months. Methods: Patients were randomized to continue on the same regimen or to switch to IDV plus liquid RTV (IDV/RTV 800 mg/100 mg q12h). Primary endpoint was the proportion of patients remaining < 500 copies/ml at 48 weeks. Results: A total of 323 patients (IDV/RTV, 162; IDV, 161) were evaluable. At 48 weeks, the proportions of patients with plasma HIV RNA < 500 copies/ml were 93%, 88% and 58% in the IDV/RTV arm versus 92% (P = 1), 86% (P = 0.87) and 74% (P = 0.003) in the IDV arm using on-treatment (OT) and intent-to-treat (ITT) [switches included (ITT, S = I) and switches = failure (ITT, S = F)] analyses respectively. Mean increase in CD4 cell count was 88 x 106/cells/l (IDV/RTV arm) and 60 x 106 cells/l (IDV arm) (P = 0.08). More patients discontinued study medication due to adverse events in the IDV/RTV arm than in the IDV arm (P < 0.001). Conclusions: Equivalence of continuing IDV q8h versus switching to IDV/RTV (liquid) q12h in suppressed stable patients was demonstrated by OT and ITT S = I analyses. However, the IDV q8h arm performed better when discontinuations were classified as failures. IDV/RTV q12h can be convenient and equally effective for patients able to tolerate it
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    Determinants of HIV Progression and Assessment of the Optimal Time to Initiate Highly Active Antiretroviral Therapy
    (2008-02-01) Jaén, Ángeles; Esteve, Anna; Miró, Josep M; Tural, Cristina; Montoliu, Alexandra; Ferrer, Elena; Riera, Melcior; Segura, Ferran; Force, Lluis; Sued, Omar; Vilaró, Josep; Garcia, Isabel; Masabeu, Angels; Altès, Jordi; Clotet, Bonaventura; Podzamczer, Daniel; Murillas, Javier; Navarro, Gemma; Gatell, Jose; Casabona, Jordi; the PISCIS Study Group
    Objective: We analyze the factors related to progression to AIDS or death in HIV-infected patients from the Proyecto para la Informatización del Seguimiento Clínico epidemiológico de los pacientes con Infección por VIH/SIDA (PISCIS) Cohort and we assess the optimal time to initiate highly active antiretroviral therapy (HAART) taking lead time into account. Methods: We selected naive patients who were AIDS-free and initiated HAART after January 1998. Statistical analyses were performed using Cox proportional hazards models. Lead time was defined as the time it took the deferred group with an early disease stage to reach the later stage. The analysis accounting for lead time was performed using multiple imputation methods based on estimates from the pre-HAART period as described elsewhere. Results: Multivariate analysis on 2035 patients (median follow-up = 34.3 months) showed significantly higher hazard ratios (HRs) for a CD4 count <200 cells/μL (HR = 3.79, 95% confidence interval [CI]: 2.18 to 6.57), HIV-1 RNA level >100,000 copies/mL (HR = 1.84, 95% CI: 1.26 to 2.69), and hepatitis C virus (HCV) coinfection (HR = 2.40, 95% CI: 1.65 to 3.49), whereas a lower risk was found for those who started HAART between January 2001 and June 2004 (HR = 0.55, 95% CI: 0.30 to 0.90). When lead time and unseen events were included, we found a higher risk of progression to AIDS among patients who deferred treatment when the CD4 count reached <200 cells/μL (HR = 2.97, 95% CI: 1.91 to 4.63) and 200 to 350 cells/μL (HR = 1.85, 95% CI: 1.03 to 3.33) compared with those who started treatment with CD4 counts from 200 to 350 cells/μL and >350 cells/μL, respectively. Conclusions: Advanced HIV disease, HCV coinfection, and early HAART period were determinants of AIDS progression or death. Lead-time analysis in asymptomatic HIV-infected patients suggests that the best time to start HAART is before the CD4 count falls to lower than 350 cells/μL.
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    Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients
    (2011) Gathe, Joseph; Andrade-Villanueva, Jaime; Santiago, Steven; Horban, Andrzej; Nelson, Mark; Cahn, Pedro; Bogner, Johannes; Spencer, David; Podzamczer, Daniel; Chan-Loi, Yong; Thuy, Nguyen; Wei, Zhang; Murray, Drulak; Quinson, Anne-Marie
    Background: This study (VERxVE) compared the efficacy and safety of the new nevirapine extended-release (NVP XR) formulation dosed once daily with NVP immediate release (IR) twice daily in treatment-naive patients. Methods: Randomized, double-blind, double-dummy, parallel group study of HIV-1-infected adult patients with baseline viral load (VL) ≥ 1,000 copies/ml and CD4(+) T-cell count of >50-<400 (males) and >50-<250 cells/mm(3) (females). Patients stratified by baseline VL (≤ 100,000/>100,000 copies/ml) were randomized 1:1 to NVP XR 400 mg once daily (plus placebo) or NVP IR 200 mg twice daily (plus placebo), both combined with tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine 200 mg once daily. Primary endpoint was sustained virological response (<50 copies/ml) through week 48 using the time to loss of virological response algorithm. Non-inferiority of NVP XR to NVP IR was tested using Cochran's statistic incorporating baseline VL stratum with pre-specified, non-inferiority margin of -10%. Results: Among 1,011 patients randomized and treated, virological response at week 48 was 81.0% (409/505) for NVP XR and 75.9% (384/506) for NVP IR with adjusted difference of 4.9% in favour of NVP XR (95% CI -0.1-10.0%), demonstrating non-inferiority of NVP XR to NVP IR. This finding was supported by secondary endpoints. The safety profile of NVP XR was similar to NVP IR, but showed numerically fewer treatment-related adverse events. Conclusions: NVP XR in combination with TDF and emtricitabine was shown to be non-inferior in efficacy to NVP IR with a similar safety and adverse event profile, with the potential for the added convenience of once-daily dosing. Trial registration: ClinicalTrials (NCT): NCT00561925.
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    HIV-1 infected patients older than 50 years. PISCIS cohort study
    (2008) Navarro, Gemma; Nogueras, Maria M.; Segura, Ferran; Casabona, Jordi; Miro, Jose M.; Murillas, Javier; Tural, Cecilio; Ferrer, Enrique; Jaén, Amelia; Force, Laura; Vilaró, Laura; García, Iván; Masabeu, Antoni; Altés, José; Esteve, Albert; Sued, Omar; Riera, Maria; Clotet, Bonaventura; Podzamczer, Daniel; Gatell, Jose; PISCIS Study Group
    Objective: The aim of this study is to characterize the ways in which older HIV-infected people differ from younger HIV-infected people. Methods: Prospective cohort study. PISCIS cohort includes newly attended HIV-infected subjects since January 1, 1998. Naive patients were selected. Two groups were defined: G1 (>or=50 years at time of diagnosis, n=493) and G2 (18-49 years, n=4511). Statistical analysis was performed using chi(2), Student's t test, Cox regression and linear mixed models. Results: G1 had different features: males (G1: 84% vs. G2: 75%, p<0.001), sexual transmission (52% vs. 32%, p<0.001), AIDS at first visit (38% vs. 22%, p<0.001). The follow-up was 6 years. Ninety-five percent of patients in G1 and 92% in G2 presented a detectable viral load (>or=500 copies/mm(3)) at the first visit (p=0.016). G1 presented lower CD4 levels with respect to G2 throughout the period but the increase of CD4 in G1 at the end of the study period was 254 cells/mm(3) whereas for G2 it was 196 cells/mm(3) (p<0.001). Mortality was 9% for G1 and 4% for G2 (p<0.001). Conclusions: HIV-infected people diagnosed at the age of 50 years or older showed different features. They showed good viral and immunological response to HAART.