Virological and immunological safety of a dose reduction strategy antiretroviral regimen with efavirenz / tenofovir / emtricitabine

• Conditions: HIV -1 infection; MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-004970-24-ES
• Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adults (= 18 years)

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

3. Standard plasmárica viral load below the limit of detection for at least 2 years.

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

5. 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.

6. Patients should be given written informed consent

7. In the opinion of the investigator, be able to follow the design of the protocol visits
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have experienced virologic failure prior to any antiretroviral regimen
2. Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine
3. Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study
4. Any cointraindicación to study drug
5. Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient
6. Uncontrolled preexisting psychiatric illness
7. Any current sign of alcoholism or other drug use.

Study & Design

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