Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject

Phase 4

Completed

• Conditions: HIV Infection
• Interventions: Drug: Darunavir/Ritonavir; Drug: Emtricitabine/tenofovir or abacavir/lamivudine; Drug: Lamivudine

• Registration Number: NCT02159599
• Lead Sponsor: Fundacion SEIMC-GESIDA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Study Start: 2014-07
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

1. Acceptance to participate in the study, signing the informed consent document before conducting any study procedures.
2. Patient with HIV infection older than 18 years.
3. Treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening
4. Plasma HIV RNA levels below 50 copies / ml for at least 6 months (two separate measurements at least 6 months with viremia <50 copies / ml between both).
5. HbsAg negative

Exclusion Criteria

1. Pregnant or breastfeeding woman

2. Evidence of Lamivudine resistance (any previous genotype with mutation M184V/I or K65R) and/or to darunavir (population genotype show any of the following mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V).

3. History of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions:

   • Do not consider an exclusion criterion if the genotype performed at the time of failure does not demonstrate resistance to lamivudine and darunavir (see criteria 2).
   • Do not consider an exclusion criteria in the absence of genotype if after the episode turns to maintain a viral load <50 copies / ml with a treatment composed of lamivudine or emtricitabine + a nucleoside + a non-nucleoside.

4. History of abandonment of treatment including lamivudine or emtricitabine, with the following exception:

   • Viral load prior to abandonment was <50 copies / ml and subsequent reintroduction of the same treatment or another treatment consisting of lamivudine or emtricitabine + a nucleoside + a non-nucleoside returns to maintain viral load below 50 copies / ml .

5. Previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine

6. Previous treatment with bitherapy or monotherapy with a regimen with a protease inhibitor that is terminated by viral rebound, when the absence of a genotypic resistance test available after viral rebound allow discard the resistance mutations either drug used.

7. The use of concomitant medication not permitted

8. Presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial

9. Any laboratory results of the following: hemoglobin<8,0 g/dl; neutrophils <750 cells/µl; platelets <50.000 cell/µl; creatinine ≥ 1,5 ULN (upper limit of normal)

10. Any clinical or analytic event that, in the investigator judgment, condition the patient safety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darunavir/Ritonavir + 2 nucleos(t)idos	Darunavir/Ritonavir	Darunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)
Darunavir/Ritonavir + 2 nucleos(t)idos	Emtricitabine/tenofovir or abacavir/lamivudine	Darunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)
Darunavir/ritonavir + Lamivudine	Darunavir/Ritonavir	Darunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)
Darunavir/ritonavir + Lamivudine	Lamivudine	Darunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)

Primary Outcome Measures

Name	Time	Method
Proportion of patients with undetectable viral load	week 48	Undetectable viral load \<50 copies/ml according to the FDA snapshot algorithm

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who maintained viral load < 50 copies/ml in all determinations	week 48	Viral load \< 50 copies/ml
Proportion of patients with undetectable viral load	Week 24	Undetectable viral load \< 50 copies/ml according to the FDA snapshot algorithm
Proportion of patients with viral load < 200 copies/ml	week 48	Proportion of patients with viral load \< 200 copies/ml according to FDA snapshot algorithm
Proportion of patients who present viral load ≥ 50 copies /ml one time	From basal visit until week 48 visit	Viral load ≥ 50 copies/ml
Proportion of patients who present viral load ≥ 50 copies /ml more tan two times	From basal visit until week 48 visit	Viral load ≥ 50 copies /ml
Median of change cells CD4/µl count from basal to week 48	week 48	CD4/µl
Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48	week 48
Change in renal function	week 48	Change in glomerular filtration
Change in proportion of patients with renal tubular dysfunction	week 48

Trial Locations

Locations (21)

Hospital Universitario de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital de La Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Complejo Hospitalario de Huelva; 🇪🇸 Huelva, Spain

Hospital Universitario Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Madrid, Spain

Hospital universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Príncipe de Asturias; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital de Mataró; 🇪🇸 Mataró, Spain

Hospital Universitario Donostia; 🇪🇸 San Sebastián, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain