Patients with HIV-1 MedDRA version: 20.0 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 100000004862
Conditions
Interventions
Trade Name: EFAVIRENZ MYLAN - 600 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/PVDC/AL
Product Name: Efavirenz
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EFAVIRENZ
CAS
Sponsors
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactLaboratorio di Ricerca Clinica
IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri"
Outcome results
None listed