Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine

HIV Clinical Trial

— A-TRI-WEEK  

Official title:

Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778413
• Other study ID #: A-TRI-WEEK
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2013
• Last updated: September 1, 2015
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2013
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.

Description:

The main objective of this study is to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per week in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (= 18 years)

• HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years.

• Standard plasma viral load below the limit of detection for at least 2 years.

• CD4 count above 350/mm3 at the time of the consideration for the study.

• Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug.

• Patients should be given written informed consent

• In the opinion of the investigator, be able to follow the design of the protocol visits

Exclusion Criteria:

• Patients who have experienced virologic failure prior to any antiretroviral regimen

• Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine

• Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study

• Any contraindication to study drug

• Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient

• Uncontrolled preexisting psychiatric illness

• Any current sign of alcoholism or other drug use.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• ATRIPLA

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Anna Cruceta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis.		24 weeks	Yes
Secondary	The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks.		24 weeks	No
Secondary	The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells		baseline and 6 months	No
Secondary	Immunological	Changes from baseline to 24 weeks in the production of TRECs, the immunological profile of activation (CD38 and HLA-DR) and senescence (CD57 and CD28) in CD4 and CD8 lineages in the proportions of naive T cells effector and memory (CCR7 and CD45RA), and changes in the levels of apoptosis in vitro by staining with annexin V.	baseline and 6 months	Yes
Secondary	Changes in plasma levels of efavirenz.		baseline and 6 months	No
Secondary	Changes in sleep quality (Pittsburgh Sleep Quality Index).		baseline and 6 months	No
Secondary	General Safety (report adverse events, serious adverse events and treatment discontinuation due to adverse events)		24 weeks	Yes
Secondary	Changes in plasma levels of vitamin D.		baseline and 6 months	No
Secondary	Changes in lipid profile.		baseline and 6 months	No
Secondary	Changes in estimated glomerular filtration rate.		baseline and 6 months	No