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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-03

Study Completion Date

2015-07-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ATRIPLA three times a week.

Atripla (600 mg/200 mg/245 mg) three times a week.

Group Type EXPERIMENTAL

ATRIPLA

Intervention Type DRUG

ATRIPLA one time a day.

Atripla (600 mg/200 mg/245 mg) one time a day.

Group Type ACTIVE_COMPARATOR

ATRIPLA

Intervention Type DRUG

Interventions

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ATRIPLA

Intervention Type DRUG

Other Intervention Names

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efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg/200 mg/245 mg

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No