Estudio primario

No clasificado

Changes in Quality of Sleep, Mood, and Other Neuropsychiatric Symptoms After Switching Dolutegravir/Lamivudine/Abacavir to Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Randomized Study of People With Human Immunodeficiency Virus With Poor Sleep Quality: GESIDA 10418

Año 2022
Revista Open forum infectious diseases
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BACKGROUND:

Although switching antiretroviral therapy (ART) in people with human immunodeficiency virus experiencing insomnia due to dolutegravir-related neurotoxicity is well founded upon evidence, there is a lack of proof in regard to the outcome of stopping dolutegravir-based ART in people without insomnia but reporting poor sleep quality.

METHODS:

This is a randomized, multicenter, open-label study to evaluate the reversibility of patient-reported sleep disturbances in patients on dolutegravir/lamivudine/abacavir without insomnia after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. The participants were randomized to switch ART at baseline or at week 4 and then completed 8 weeks of darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Our primary objective was to compare changes in sleep quality between arms at week 4. Secondary objectives were to compare changes in mood and neuropsychiatric symptoms (NS) at week 4 and 4 and 8 weeks after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. The participants completed a survey, including the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression scale (HADS), and specific questions to explore NS, at each visit to assess those objectives.

RESULTS:

We included 72 participants. The results show that study arms were similar at baseline; however, at week 4, PSQI scores remained unchanged with dolutegravir/lamivudine/abacavir, whereas patients improved significantly after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Similar differences between arms were also observed in HADS and NS changes. At weeks 4 and 8 after all participants switched to darunavir/cobicistat/emtricitabine/tenofovir alafenamide, we have observed significant improvements in PSQI and HAD scores and in NS.

CONCLUSIONS:

In patients reporting subclinical sleep disturbances without insomnia, switching from dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide was associated with better sleep quality and improvements in mood and NS.

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Estudio primario

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A phase IV study to assess the feasibility of substituting double ritonavir-boosted protease inhibitors (PI) with ritonavir-boosted darunavir (DRV/r) in HIV-infected individuals with viral suppression on highly active antiretroviral therapy (HAART)

Año 2007
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Prezista Product Name: Darunavir Pharmaceutical Form: Tablet Trade Name: Norvir Product Name: Ritonavir Pharmaceutical Form: Capsule, soft

CONDITION:

HIV PRIMARY OUTCOME:

Main Objective: To investigate the rates of continued virological suppression in subjects switching a double ritonavir‐boosted PI for DRV/r to 48 weeks. Primary end point(s): The proportion of subjects maintaining viral suppression (less than 50 copies/ml) at 48 weeks. Secondary Objective: •To investigate the immunological response in subjects switching from double ritonavir‐boosted PI to DRV/r.; •To investigate whether it is possible to improve the quality of life in individuals by changing from double ritonavir‐boosted PI to DRV/r.; •An evaluation of the safety of switching to DRV/r ; •To assess the impact of switching from double ritonavir‐boosted PI to DRV/r on insulin sensitivity by euglycaemic clamp method in a sub group of 10 patients.; ; ;

INCLUSION CRITERIA:

‐ HIV‐1 infected as documented by a licensed HIV‐1 antibody ELISA test ‐ At least 18 years of age ‐ Currently on an antiretroviral regimen including a ritonavir boosted double protease inhibitor ‐ The subject is virologically suppressed with a viral load < 50 copies/mL for six months or longer ‐ The subject has a CD4+ count above 100 cells/mL ‐ = 3 DRV associated mutations on previous genotypic resistance test –or if no resistance test available, likely to have = 4 protease inhibitor mutations based on their clinical history ‐ If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception ‐ The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1

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Estudio primario

No clasificado

PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir

Año 2009
Registro de estudios clinicaltrials.gov
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The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple increasing oral doses followed by a single dose of TMC310911 to assess the potential boosting effect on the latter compound. In this study, two investigational new drugs are involved, TMC558445 and TMC310911.

The study has been amended as follows:

TMC558445 will be administered either twice a day (b.i.d.) or once daily (q.d.). A single 300 mg or 600 mg dose of TMC310911 will be administered under fasted or fed conditions. The boosting effect on Darunavir will be investigated.

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Estudio primario

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METABOLIK (Metabolic Evaluation in Treatmentnaives Assessing the impact of two Boosted protease inhibitors on LIpids and other markers): Week 48 comparison of body fat changes in ARVnaive subjects receiving darunavir/ritonavir- or atazanavir/ritonavir-based therapy

Año 2010
Revista Antiviral Therapy
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Objectives/aim: Limited data exist on the effects of darunavir/ritonavir (DRV/r) on body composition. METABOLIK was a 48-week, randomized, open-label, Phase 4, exploratory, multicentre study that assessed changes in metabolic parameters and biomarkers in HIV-infected, antiretroviral-naive adults receiving DRV/r- versus atazanavir/ritonavir (ATV/r)-based therapy. The primary analysis showed limited differences between arms in fasting triglycerides at week 12. We report changes in adipose tissue and subjects' perceptions of body changes over 48 weeks. Methods: Subjects were randomized 1:1 to DRV/r 800/100 mg once daily (qd) or ATV/r 300/100 mg qd, both with fixed-dose emtricitabine/tenofovir 200/300 mg qd. CT scans were performed at the L4-L5 level and mid-thigh at baseline and week 48, and centrally Table Presented analysed for total (TAT), subcutaneous (SAT), visceral (VAT) and peripherial (PAT) adipose tissue. Self-reported 'Assessment of Body Change and Distress' questionnaire (time recall period past 4 weeks) was administered at baseline and weeks 12 and 48. Results: 65 patients (34 and 31 in the DRV/r and ATV/r arms, respectively) were treated. 86% were male. Median (range) age was 36.0 (19-65) years. For the DRV/r and ATV/r arms, respectively, median (range) baseline CD4 count was 266.5 (10-532) and 316 (39-813) cells/mm3, and median (range) log10 HIV-1 RNA was 5.1 (2.8-6.4) and 4.7 (2.6-5.8) copies/ml. Baseline TAT, SAT, VAT and VAT/SAT ratio did not change considerably within or between arms (Table 1). Changes in PAT were larger with DRV/r than ATV/r. Subjects' perceptions of body changes from baseline to week 48 generally improved and were similar between arms, except that more subjects reported increases in waist and chest size with DRV/r. Conclusion/discussion: This first prospective study of changes in body composition with DRV/r versus ATV/r suggests that changes in body composition are comparable between these two boosted protease inhibitors, and that subjects' perceptions of these changes were essentially improved over time.

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Estudio primario

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TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously

Año 2006
Registro de estudios clinicaltrials.gov
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This is an open label study (no placebos are used; all patients will receive the true medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously received anti-HIV drugs), HIV 1 infected patients.

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Estudio primario

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ESTUDIO PILOTO, ABIERTO, COMPARATIVO Y ALEATORIZADO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE DARUNAVIR/RITONAVIR 900/100 MG UNA VEZ AL DIA COMO ESTRATEGIA DE SIMPLIFICACION DEL TRATAMIENTO ANTIRRETROVIRAL

Año 2007
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Prezista Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

darunavir CAS Number: 206361‐99‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Norvir Pharmaceutical Form: Capsule, soft INN or Proposed

INN:

RITONAVIR CAS Number: 155213675 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐

CONDITION:

Pacientes con infección por el VIH. ; MedDRA version: 9.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection ; MedDRA version: 9.1 Level: LLT Classification code 10008922 Term: Chronic infection with

HIV INCLUSION CRITERIA:

1. Edad igual o superior a 18 años. 2. Infección documentada por el VIH. 3. Tratamiento estable con darunavir/ritonavir 600/100 mg cada 12 horas durante al menos 4 semanas. 4. Carga viral del VIH en plasma <50 copias/mL durante al menos 12 semanas. 5. Disponibilidad de un test de resistencias (genotipo o fenotipo virtual) previo al inicio del tratamiento con darunavir. 6. Presencia de un vIQ para darunavir igual o superior a 2. 7. Sujeto capaz de seguir el periodo de tratamiento. 8. Si es una mujer debe no estar en edad fértil (definido como al menos un año desde la menopausia o sometida a cualquier técnica quirúrgica de esterilización), o comprometerse a usar un método anticonceptivo de barrera durante el estudio. 9. Firma del consentimiento informado. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elder

PRIMARY OUTCOME:

Main Objective: Evaluar la eficacia y la seguridad de simplificar el tratamiento con darunavir/ritonavir a 900/100 mg una vez al día en pacientes infectados por el VIH que mantienen una carga viral del VIH en plasma <50 copias/mL mientras reciben tratamiento con darunavir/ritonavir a dosis de 600/100 mg dos veces al día y que presentan un vIQ (Cociente inhibitorio virtual) para DRV igual o superior 2. Primary end point(s): ‐ Comparar la proporción de pacientes con carga viral del VIH en plasma < 50 copias/mL; ; Se considerarán endpoint secundarios:; ; ‐ Evaluar la proporción de pacientes que presenta un vIQ para DRV³2 durante el tratamiento con DRV/ritonavir a dosis de 600/100 mg cada 12 horas.; ‐ Comparar la proporción de pacientes que mantiene un vIQ para DRV ³1,5 durante el tratamiento con DRV/ritonavir a dosis de 600/100 mg cada 12 horas o 900/100 mg cada 24 horas.; ‐ Comparar la proporción de pacientes que mantiene una concentración valle de DRV igual o superior a 550 ng/mL durante el tratamiento con DRV/ritonavir a dosis de 600/100 mg cada 12 horas o 900/100 mg cada 24 horas.; ‐ Comparar los cambios en el recuento de linfocitos CD4 tras 24 semanas de seguimiento.; ‐ Comparar la incidencia y la severidad de los acontecimiento adversos tras 24 semanas de seguimiento.; Secondary Objective: 1. Evaluar la proporción de pacientes que presenta un vIQ para DRV³2 durante el tratamiento con DRV/ritonavir a dosis de 600/100 mg cada 12 horas.; 2. Comparar la proporción de pacientes que mantiene un vIQ para DRV ³1,5 durante el tratamiento con DRV/ritonavir a dosis de 600/100 mg cada 12 horas o 900/100 mg cada 24 horas.; 3. Comparar la proporción de pacientes que mantiene una concentración valle de DRV ³550 ng/mL durante el tratamiento con DRV/ritonavir a dosis de 600/100 mg cada 12 horas o 900/100 mg cada 24 horas.; 4. Comparar los cambios en el recuento de linfocitos CD4 tras 24 semanas de seguimiento.; 5. Comparar la incidencia y la severidad de los acontecimiento adversos tras 24 semanas de seguimiento.;

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Estudio primario

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Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial.

Año 2022
Revista Journal of the International AIDS Society
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INTRODUCTION:

ACTG A5288 was a strategy trial conducted in diverse populations from multiple continents of people living with HIV (PLWH) failing second-line protease inhibitor (PI)-based antiretroviral therapy (ART) from 10 low- and middle-income countries (LMICs). Participants resistant to lopinavir (LPV) and/or multiple nucleotide reverse transcriptase inhibitors started on third-line regimens that included raltegravir (RAL), darunavir/ritonavir (DRV/r) and/or etravirine (ETR) according to their resistance profiles. At 48 weeks, 87% of these participants achieved HIV-1 RNA ≤200 copies/ml. We report here long-term outcomes over 144 weeks.

METHODS:

Study participants were enrolled from 2013 to 2015, prior to the availability of dolutegravir in LMICs. "Extended Follow-up" of the study started after the last participant enrolled had reached 48 weeks and included participants still on antiretroviral (ARV) regimens containing RAL, DRV/r and/or ETR at that time. RAL, DRV/r and ETR were provided for an additional 96 weeks (giving total follow-up of ≥144 weeks), with HIV-1 RNA measured at 48 and 96 weeks and CD4 count at 96 weeks after entry into Extended Follow-up. Proportion of participants with HIV-1 RNA ≤200 copies/ml was estimated every 24 weeks, using imputation if necessary to handle the different measurement schedule in Extended Follow-up; mean CD4 count changes were estimated using loess regression.

RESULTS AND DISCUSSION:

Of 257 participants (38% females), at study entry, median CD4 count was 179 cells/mm3 , and HIV-1 RNA was 4.6 log10 copies/ml. Median follow-up was 168 weeks (

IQR:

156-204); 15 (6%) participants were lost to follow-up and 9 (4%) died. 27/246 (11%), 26/246 (11%) and 13/92 (14%) of participants who started RAL, DRV/r and ETR, respectively, discontinued these drugs; only three due to adverse events. 87%, 86%, 83% and 80% of the participants had HIV-1 RNA ≤200 copies/ml at weeks 48, 96, 144 and 168 (95% CI at week 168: 74-85%), respectively. Mean increase from study entry in CD4 count at week 168 was 265 cells/mm3 (95% CI 247-283).

CONCLUSIONS:

Third-line regimens comprising of RAL, DRV/r and/or ETR were very well tolerated and had high rates of durable virologic suppression among PLWH in LMICs who were failing on second-line PI-based ART prior to the availability of dolutegravir.

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Estudio primario

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Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-inferiority trial.

Año 2022
Revista The lancet. HIV
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BACKGROUND:

WHO guidelines recommend dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) for second-line HIV therapy, with NRTI switching from first-line tenofovir to zidovudine. We aimed to examine whether dolutegravir is non-inferior to darunavir, the best-in-class protease inhibitor drug, and whether maintaining tenofovir in second-line therapy is non-inferior to switching to zidovudine.

METHODS:

In this prospective, multicentre, open-label, factorial, randomised, non-inferiority trial (NADIA), participants with confirmed HIV first-line treatment failure (HIV-1 RNA ≥1000 copies per mL) were recruited at seven clinical sites in Kenya, Uganda, and Zimbabwe. Following a 2 × 2 factorial design and stratified by site and screening HIV-1 RNA concentration, participants were randomly assigned (1:1:1:1) to receive a 96-week regimen containing either dolutegravir (50 mg once daily) or ritonavir-boosted darunavir (800 mg of darunavir plus 100 mg of ritonavir once daily) in combination with either tenofovir (300 mg once daily) plus lamivudine (300 mg once daily) or zidovudine (300 mg twice daily) plus lamivudine (150 mg twice daily). The NRTI drugs allocated by randomisation were administered orally in fixed-dose combination pills; other drugs were administered orally as separate pills. The previously reported primary outcome was the proportion of participants with a plasma HIV-1 RNA concentration of less than 400 copies per mL at 48 weeks. Here, we report the main secondary outcome: the proportion of participants with a plasma HIV-1 RNA concentration of less than 400 copies per mL at 96 weeks (non-inferiority margin 12%). We analysed this outcome and safety outcomes in the intention-to-treat population, which excluded only those who were randomly assigned in error and withdrawn before receiving trial drugs. This study was registered at ClinicalTrials.gov, NCT03988452, and is complete.

FINDINGS:

Between July 30 and Dec 18, 2019, we screened 783 patients and enrolled 465. One participant was randomly assigned in error and immediately withdrawn. The remaining 464 participants were randomly assigned to receive either dolutegravir (n=235) or ritonavir-boosted darunavir (n=229) and to receive lamivudine plus either tenofovir (n=233) or zidovudine (n=231). At week 96, 211 (90%) of 235 participants in the dolutegravir group and 199 (87%) of 229 participants in the darunavir group had HIV-1 RNA less than 400 copies per mL (percentage point difference 2·9, 95% CI -3·0 to 8·7), indicating non-inferiority. Nine (4%) participants (all in the dolutegravir group) developed dolutegravir resistance; no participants developed darunavir resistance (p=0·0023). In the other randomised comparison, 214 (92%) of 233 patients in the tenofovir group and 196 (85%) of 231 patients in the zidovudine group had HIV-1 RNA less than 400 copies per mL (percentage point difference 7·0, 95% CI 1·2 to 12·8), showing non-inferiority and indicating the superiority of tenofovir (p=0·019). The proportions of participants with any grade 3-4 adverse event were similar between the dolutegravir (26 [11%]) and darunavir (28 [12%]) groups and between the tenofovir (22 [9%]) and zidovudine (32 [14%]) groups. There were no deaths related to study medication.

INTERPRETATION:

Dolutegravir-based and darunavir-based regimens maintain good viral suppression during 96 weeks; dolutegravir is non-inferior to darunavir but is at greater risk of resistance in second-line therapy. Tenofovir should be continued in second-line therapy, rather than being switched to zidovudine.

FUNDING:

Janssen.

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Estudio primario

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Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir for participants with less than 50 HIV RNA copies per mL (WRHI 052): a randomised, open-label, phase 3, non-inferiority trial.

Año 2019
Revista The lancet. HIV
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BACKGROUND:

Pilot studies suggest that ritonavir-boosted darunavir could show high efficacy at doses below those currently approved. We investigated whether switch to 400 mg of darunavir boosted with 100 mg ritonavir once daily could show equivalent efficacy to continuation of ritonavir-boosted lopinavir (a protease inhibitor commonly used in low-income and middle-income countries) for individuals with HIV RNA suppression.

METHODS:

In the WRHI 052 study, a randomised, parallel-group, open-label, non-inferiority phase 3 trial, adults who were HIV-1 positive were enrolled in Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa. Eligible participants were 18 years or older, who tolerated ritonavir-boosted lopinavir in combination with two nucleoside analogues (standard of care) for 6 months or more, and had plasma HIV-1 RNA of less than 50 copies per mL within 60 days of enrolment. We randomly assigned participants (1:1), using a computer-generated randomisation plan, to switch to darunavir (400 mg) boosted with ritonavir (100 mg) once daily or remain on ritonavir-boosted lopinavir (800 mg [plus 200 mg ritonavir]), with nucleoside analogues left unchanged. The primary endpoint was the proportion of patients with less than 50 HIV-1 RNA copies per mL at week 48 (US Food and Drug Administration snapshot algorithm; non-inferiority margin -4%). Primary and safety analyses included participants receiving at least one dose of darunavir boosted with ritonavir. This trial is registered with ClinicalTrials.gov, number NCT02671383.

FINDINGS:

Between June 30, 2016, and June 15, 2017, 148 participants were assigned to ritonavir-boosted darunavir 400 mg and 152 continued on their lopinavir-containing regimen. Four (3%) patients in the darunavir group and three (2%) in the lopinavir group discontinued before week 48. At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%. More participants taking darunavir (30 [20%] participants) had drug-related adverse events than those on lopinavir (eight [5%]), but the adverse events were generally asymptomatic and resolved when switching back to lopinavir. Elevated liver transaminase in three (1%; one symptomatic) darunavir participants led to study withdrawal; all transaminase elevations resolved on restarting lopinavir.

INTERPRETATION:

Low-dose ritonavir-boosted darunavir might be a safe and efficacious switch option to maintain HIV suppression for patients on lopinavir. However, an adequately powered and designed study in viraemic participants is needed.

FUNDING:

South African Medical Research Council, United States Agency for International Development, and US National Institute of Allergy and Infectious Diseases.

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No clasificado

A phase IV, two-arm, open-label, single-centre randomised pilot study to assess the feasibility of immeidate or deferred switching of HIV-infected individuals intolerant of efavirenz, ritonavir-boosted lopinavir or ritonavir-boosted atazanavir, to ritonavir-boosted darunavir

Año 2008
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Norvir Product Name: Ritonavir Product Code: NA Pharmaceutical Form: Capsule, soft Trade Name: Kaletra Product Name: Lopinavir/ritonavir Pharmaceutical Form: Film‐coated tablet Trade Name: Reyataz Product Name: Atazanvir Pharmaceutical Form: Capsule, hard Trade Name: Sustiva Product Name: Efavirenz Pharmaceutical Form: Film‐coated tablet Trade Name: Prezista Product Name: Prezista Product Code: TMC114 Pharmaceutical Form: Film‐coated tablet

CONDITION:

HIV PRIMARY OUTCOME:

Main Objective: To investigate whether switching individuals intolerant to NNRTI/PI, to ritonavir boosted darunavir is associated with resolution of toxicity Primary end point(s): The improvement of NNRTI/PI associated toxicity after 4 weeks of therapy with ritonavir boosted darunavir Secondary Objective: •To investigate the change in CD4 count in individuals switching from NNRTI/PI to ritonavir boosted darunavir ; •To investigate continued virological suppression at levels of < 400 copies /ml and 50 copies /ml in individuals switching from NNRTI/PI to ritonavir boosted darunavir ; •To investigate changes in quality of life in individuals switching from NNRTI/PI to ritonavir boosted darunavir; •To investigate changes in fasting lipids‐cholesterol and triglycerides‐ in individuals switching from NNRTI/PI to ritonavir boosted darunavir; •To investigate the impact of switching on adherence ; •To investigate the impact of switching on patient‐perceived distress associated with tolerability issues ;

INCLUSION CRITERIA:

A subject will be eligible for inclusion in the study only if ALL of the following criteria apply: •HIV‐1 infected as documented by a licensed HIV‐1 antibody ELISA test •The subject is currently on an antiretroviral regimen comprising at least three licensed antiretroviral agents including efavirenz, ritonavir‐boosted lopinavir or ritonavir‐boosted atazanavir •Symptomatic toxicity associated with the NNRTI/PI after at least 12 weeks of therapy •The subject is virologically suppressed with a viral load < 50 copies/ml •The subject has a CD4+ count above 50 cells/ml •If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception •No previous exposure to Darunavir Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects fo

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