A RANDOMIZED BIOEQUIVALENCE STUDY OF EFAVIRENZ GENERIC DRUG AND SUSTIVA® (TABLETS 600 mg) IN PATIENTS WITH HIV-1
- Conditions
- Patients with HIV-1MedDRA version: 20.0Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-003278-34-IT
- Lead Sponsor
- IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1.Able to understand and willing to sign written informed consent form, obtained before any screening procedure;
2.Male or female, aged 18 years or older;
3.Body Mass Index> 18.5 Kg/m2 to < 30.0 Kg/m2;
4.Patient currently receiving an antiretroviral regimen containing Efavirenz by a period of 6 months before the screening visit;
5.Documented plasma HIV-1 RNA levels <37 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is >37 copies/mL, Abbott RT-PCR kit HIV-1) for 6 months preceding the screening visit;
6.Willing and able to comply with protocol requirements;
7.A female subject is eligible to enter the study if it is confirmed that she is:
a.Not pregnant or breastfeeding;
b.With a negative serum pregnancy test at screening visit;
c.Of non-childbearing potential (i.e., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women> 54 years of age with cessation (for >12 months) of previously occurring menses and appropriate post-menopausal FSH elevation, or
d.Of childbearing potential and agrees to utilize highly effective protocol-specified contraceptive method or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last study drug dose;
e.utilizes hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Evidence of gastro-intestinal diseases influencing drug absorption;
2.Evidence of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.);
3.Evidence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy
4.Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance;
5.Participation in any clinical trial within last three months;
6.Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication;
7.Presence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening;
8.Hepatic transaminases (AST and ALT) >3 × upper limit of normal (ULN)
9.Not adequate renal function in terms of estimated glomerular filtration rate <50 mL/min according to the Cockcroft-Gault formula: Male: (140 – age in years) x (wt in kg) = CLcr (mL/min)72 x (serum creatinine in mg/dL); Female: (140 – age in years) x (wt in kg) x 0.8 = CLcr (mL/min)72 x (serum creatinine in mg/dL).
10.Any change to the antiretroviral combination in the month preceding the first study drug administration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess the bioequivalence at steady state, in line with clinical practice, of Efavirenz (Mylan) tablets 600 mg and Sustiva® 600 mg tablets in patients with HIV-1. ;Secondary Objective: To monitor the safety and tolerability profile of Efavirenz and Sustiva®.;Primary end point(s): The following primary pharmacokinetic parameters will be determined: AUC(0-24h) and Cmaxss. Tmaxss and trough levels will also be determined, as secondary pharmacokinetic parameters. ;Timepoint(s) of evaluation of this end point: Endpoint detected after 21 days of drug administration for each treatment period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety and tolerability profile of Efavirenz and Sustiva® will be monitored throughout the study for adverse events (all grades), serious adverse events, any adverse events requiring drug interruption or discontinuation, changes in laboratory values, and physical examination findings.;Timepoint(s) of evaluation of this end point: 42 days