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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anna Cruceta
• Treatments: Efavirenz; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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.