Role of a switch to an once-daily regimen of antiretroviral therapy on HIV-DNA levels and immune activation.

Role of a switch strategy to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (QUAD) on HIV reservoir and immune activation. - STRIBILD spontaneous clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004015-36-IT

Enrollment

Registered

2014-10-23

Start date

2015-02-16

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Human Immunodeficiency Virus (HIV-1) Infection

Interventions

Trade Name: STRIBILD Product Name: STRIBILD Pharmaceutical Form: Film-coated tablet INN or Proposed INN: EMTRICITABINE CAS Number: 143491-57-0 Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - HIV-infected - HAART with TVD+PI/r for at least 3 years - any current CD4 count - HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - patients in the acute phase of HIV infection - patients enrolled in one or more investigational drug protocols which may impact immune-virological response - patients who are, according to investigators, unable to complete the study dosing period and protocol evaluations and assessment - patients who are pregnant or breastfeeding - patients suffering from any serious medical condition which in the opinion of the investigators might compromise the safety of the subject - patients with creatinine clearance5 times the upper limit of normality - patients who have received HIV-1 immunotherapeutic molecule or vaccine - patients with a history of allergy to the drug under study or any excipients therein - patients with a history of genotypic or phenotypic resistance to the drugs under study (baseline evaluation) -

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether the switch to elvitegravir/cobicistat/emtricitabine/tenofovir (STRIBILD™) is associated to a reduction of HIV DNA and T-cell immune activation as compared to levels observed before switch from a PI based regimen;Secondary Objective: To evaluate the effect of switch to STRIBILD™on immune parameters of T-cell homeostasis and inflammation;Primary end point(s): Reduction in total and integrated HIV DNA and T-cell activation following switch to STRIBILD™ therapy for 6 months;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To evaluate whether the switch to elvitegravir/cobicistat/emtricitabine/tenofovir (STRIBILD™) is associated to a reduction of HIV DNA and T-cell immune activation as compared to levels observed before switch from a PI based regimen;Secondary Objective: To evaluate the effect of switch to STRIBILD™on immune parameters of T-cell homeostasis and inflammation;Primary end point(s): Reduction in total and integrated HIV DNA and T-cell activation following switch to STRIBILD™ therapy for 6 months;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): • modifications of parameters of T-lymphocyte maturation and immune inflammation/activation following switch to STRIBILD™ therapy for 6 months • proportion of patients keeping virologic suppression (i.e. HIV-RNA<40 cp/ml) following switch to STRIBILD™ therapy for 6 months • safety assessment following switch to STRIBILD™ therapy for 6 months ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): • modifications of parameters of T-lymphocyte maturation and immune inflammation/activation following switch to STRIBILD™ therapy for 6 months • proportion of patients keeping virologic suppression (i.e. HIV-RNA<40 cp/ml) following switch to STRIBILD™ therapy for 6 months • safety assessment following switch to STRIBILD™ therapy for 6 months ;Timepoint(s) of evaluation of this end point: 6 months

—

Countries

Italy

Contacts

Public ContactAntonella D'Arminio Monforte

AZIENDA OSPEDALIERA SAN PAOLO

antonella.darminio@unimi.it00390281843045

Outcome results

None listed

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