Phase 4 clinical trial to evaluate the effect on immune recovery of antiretroviral treatment of three drugs versus two in in HIV-infected patients but not dectactable in blood.

Phase 4 clinical trial, randomized to evaluate the effect on immune recovery of triple antiretroviral maintenance therapy (elvitegravir / cobicistat 150/150 mg + tenofovir + emtricitabine alapenamide 10 mg 200 mg) versus simplification of combination therapy (dolutegravir + lamivudine or darunavir / Cobicistat + lamivudine) in HIV-infected patients with sustained undetectable viremia.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005226-11-ES

Enrollment

180

Registered

2017-01-25

Start date

2017-04-04

Completion date

Unknown

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with HIV infection on stable therapy (= 6 months) with triple therapy and undetectable viremia for = 1 year. MedDRA version: 19.1 Level: LLT Classification code 10049838 Term: HIV viral load undetectable System Organ Class: 100000004848 MedDRA version: 19.1 Level: PT Classification code 10077716 Term: HIV viraemia System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Tivicay® Product Name: Dolutegravir Pharmaceutical Form: Tablet Trade Name: Lamivudina Teva Product Name: Lamivudina Pharmaceutical Form: Tablet Trade Name: Rezolsta® Product Name: Darun

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with HIV infection and age = 18 years. - Initiation of antiretroviral treatment after 01/01/2013 - Undetectable viremia (=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Presence of major resistance mutations to any of the study drugs. - Opportunistic infections active at the time of inclusion. - Pregnancy at the time of inclusion or during the follow-up period. - Active co-infection with B or C virus of hepatitis. - Cirrhosis, portal hypertension and / or hypersplenism of any etiology. - Past or current neoplasms of steroid treatment, immunomodulators, or chemotherapy - Laboratory abnormalities grade 3 or 4. - Concomitant use of drugs with higher drug interactions with study drugs, according to respective product data sheets. - Estimated creatinine clearance 200 copies in two consecutive determinations, during follow-up will be excluded from the analysis.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effect on immune recovery maintaining a triple antiretroviral therapy (elvitegravir / cobicistat 150/150 mg + tenofovir + emtricitabine alafenamide 10 mg 200 mg) versus combination therapy simplification (dolutegravir plus lamivudine or darunavir / cobicistat plus lamivudine) after 48 weeks Of treatment in HIV-infected patients with sustained undetectable viremia.;Secondary Objective: Evaluate whether a triple therapy based on (elvitegravir / cobicistat 150/150 mg + tenofovir alafenamide 10 mg + emtricitabine 200 mg) will lead to a greater decrease in immune activation and inflammation compared to simplification to bitherapy (dolutegravir plus lamivudine or darunavir / Cobicistat plus lamivudine) in HIV-infected patients and sustained undetectable viremia.;Primary end point(s): Changes in the CD4 + / CD8 + T lymphocyte ratio after 48 weeks of treatment.;Timepoint(s) of evaluation of this end point: After 48 weeks of treatment.	—

Measure

Time frame

Main Objective: Evaluate the effect on immune recovery maintaining a triple antiretroviral therapy (elvitegravir / cobicistat 150/150 mg + tenofovir + emtricitabine alafenamide 10 mg 200 mg) versus combination therapy simplification (dolutegravir plus lamivudine or darunavir / cobicistat plus lamivudine) after 48 weeks Of treatment in HIV-infected patients with sustained undetectable viremia.;Secondary Objective: Evaluate whether a triple therapy based on (elvitegravir / cobicistat 150/150 mg + tenofovir alafenamide 10 mg + emtricitabine 200 mg) will lead to a greater decrease in immune activation and inflammation compared to simplification to bitherapy (dolutegravir plus lamivudine or darunavir / Cobicistat plus lamivudine) in HIV-infected patients and sustained undetectable viremia.;Primary end point(s): Changes in the CD4 + / CD8 + T lymphocyte ratio after 48 weeks of treatment.;Timepoint(s) of evaluation of this end point: After 48 weeks of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Changes in CD4 + / CD8 + T lymphocyte ratio after 96 weeks of treatment. Changes after 48 and 96 weeks of treatment in: Immunoactivation measured as HLA-DR and CD38 expression on CD4 + and CD8 + T lymphocytes and plasma levels of sCD14. Expression of the following markers on CD4 + and CD8 + T lymphocytes: Ki67, PD-1, CD57, TRAIL, Annexin V and CD31. Concentrations of the following proinflammatory mediators: IL-1ß, IL-1ra, IL-2, IL-6, IL-10, IL-17, IFN-a and ?, IP-10, MIP-1 / 1ß and dimers D. Changes in microbial translocation measured by plasma concentrations of LPS and 16S rDNA. Changes in proviral DNA (HIV-DNA) in PBMCs.;Timepoint(s) of evaluation of this end point: Changes after 48 and 96 weeks of treatment according to variable.	—

Measure

Time frame

Secondary end point(s): Changes in CD4 + / CD8 + T lymphocyte ratio after 96 weeks of treatment. Changes after 48 and 96 weeks of treatment in: Immunoactivation measured as HLA-DR and CD38 expression on CD4 + and CD8 + T lymphocytes and plasma levels of sCD14. Expression of the following markers on CD4 + and CD8 + T lymphocytes: Ki67, PD-1, CD57, TRAIL, Annexin V and CD31. Concentrations of the following proinflammatory mediators: IL-1ß, IL-1ra, IL-2, IL-6, IL-10, IL-17, IFN-a and ?, IP-10, MIP-1 / 1ß and dimers D. Changes in microbial translocation measured by plasma concentrations of LPS and 16S rDNA. Changes in proviral DNA (HIV-DNA) in PBMCs.;Timepoint(s) of evaluation of this end point: Changes after 48 and 96 weeks of treatment according to variable.

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Countries

Spain

Contacts

Public ContactUICEC-HUVR

Unidad de Investigación Clínica y ensayos Clínicos

claram.rosso.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026