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 1

• Conditions: Adult patients with HIV infection on stable therapy (= 6 months) with triple therapy and undetectable viremia for = 1 year.; MedDRA version: 19.1Level: LLTClassification code 10049838Term: HIV viral load undetectableSystem Organ Class: 100000004848; MedDRA version: 19.1Level: PTClassification code 10077716Term: HIV viraemiaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-005226-11-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-25
• Last Update Posted: 10 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

- Patients with HIV infection and age = 18 years.
- Initiation of antiretroviral treatment after 01/01/2013
- Undetectable viremia (<20 copies / ml for at least one year) with triple therapy.
- Nadir and CD4 + T lymphocyte count =200 / µl at the time of inclusion.
Informed written consent.
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 <50ml / min.
- Withdrawal of informed consent.
- Patients who do not complete the follow-up period or with virological failure, defined as viremia> 200 copies in two consecutive determinations, during follow-up will be excluded from the analysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in CD4 + / CD8 + T lymphocyte ratio after 96 weeks of treatment.<br>Changes after 48 and 96 weeks of treatment in:<br> Immunoactivation measured as HLA-DR and CD38 expression on CD4 + and CD8 + T lymphocytes and plasma levels of sCD14.<br> Expression of the following markers on CD4 + and CD8 + T lymphocytes: Ki67, PD-1, CD57, TRAIL, Annexin V and CD31.<br> 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.<br> Changes in microbial translocation measured by plasma concentrations of LPS and 16S rDNA.<br> 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.