Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine (A-TRI-WEEK)

Anna Cruceta

Status and phase

Completed

Phase 4

Conditions

HIV

Treatments

Drug: ATRIPLA

Study type

Interventional

Funder types

Other

Identifiers

NCT01778413

A-TRI-WEEK

Details and patient eligibility

About

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

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.