Clinical trial NCT01778413: Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
Official title: Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis.
timeFrame: 24 weeks
Secondary outcomes:
measure: The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks.
timeFrame: 24 weeks
measure: The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells
timeFrame: baseline and 6 months
measure: Immunological
timeFrame: baseline and 6 months
measure: Changes in plasma levels of efavirenz.
timeFrame: baseline and 6 months
measure: Changes in sleep quality (Pittsburgh Sleep Quality Index).
timeFrame: baseline and 6 months
measure: General Safety (report adverse events, serious adverse events and treatment discontinuation due to adverse events)
timeFrame: 24 weeks
measure: Changes in plasma levels of vitamin D.
timeFrame: baseline and 6 months
measure: Changes in lipid profile.
timeFrame: baseline and 6 months
measure: Changes in estimated glomerular filtration rate.
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial Barcelona
Study officials:
affiliation: Hospital Clínic i Provincial de Barcelona
name: Esteban Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guardo AC, Zarama A, Gonzalez T, Bargallo ME, Rojas J, Martinez E, Plana M, Sanchez-Palomino S. Effects on immune system and viral reservoir of a short-cycle antiretroviral therapy in virologically suppressed HIV-positive patients. AIDS. 2019 May 1;33(6):965-972. doi: 10.1097/QAD.0000000000002169.
citation: Rojas J, Blanco JL, Sanchez-Palomino S, Marcos MA, Guardo AC, Gonzalez-Cordon A, Lonca M, Tricas A, Rodriguez A, Romero A, Miro JM, Mallolas J, Gatell JM, Plana M, Martinez E. A maintenance 3-day-per-week schedule with the single tablet regimen efavirenz/emtricitabine/tenofovir disoproxil fumarate is effective and decreases sub-clinical toxicity. AIDS. 2018 Jul 31;32(12):1633-1641. doi: 10.1097/QAD.0000000000001843.