Darunavir/ritonavir
DrugDarunavir/ritonavir (800/100 mg): QD (quaque die )
Other names: Prezista/Norvir
NCT Number: NCT02159599
This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Darunavir/ritonavir (800/100 mg): QD (quaque die )
Other names: Prezista/Norvir
Lamivudine (300mg) : QD
Other names: Epivir
Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD
Other names: Truvada or Kivexa
Time frame: week 48
Undetectable viral load <50 copies/ml according to the FDA snapshot algorithm
Time frame: Week 24
Undetectable viral load < 50 copies/ml according to the FDA snapshot algorithm
Time frame: week 48
Proportion of patients with viral load < 200 copies/ml according to FDA snapshot algorithm
Time frame: From basal visit until week 48 visit
Viral load ≥ 50 copies/ml
Time frame: From basal visit until week 48 visit
Viral load ≥ 50 copies /ml
Time frame: week 48
Viral load < 50 copies/ml
Time frame: week 48
CD4/µl
Time frame: week 48
Time frame: week 48
Change in glomerular filtration
Time frame: week 48
Time frame: Week 48
Mutations in patients viral failure
Time frame: week 48
Fundacion SEIMC-GESIDA
Other
An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppressed Plasma Viremia
Acronym: DUAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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