Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT01736761
Eligibility Criteria:
Inclusion Criteria:
* Patient has signed and dated informed consent document, confirming their knowledge of the pertinent aspects of the study and willingness to comply with all study requirements, prior to screening procedures.
* Male or female aged 18 to 65 years.
* HIV-1 infected with ≤ 14 days total exposure to antiretroviral therapy - prior antiretrovirals as post-exposure prophylaxis permissible if documented negative test at 3 months following exposure. If patient has previously taken up to and including 14 days antiretroviral therapy during HIV-1 infection, this must not be within 12 weeks of the screening visit and there must be an available genotypic resistance test after last intake which indicates full viral susceptibility to study medication.
* CD4 count \>50 cells/mm3 at screening.
* HIV-1 RNA \> 1000 copies/mL at screening.
* Women of childbearing potential (WoCBP); negative urine β-hCG pregnancy test at screen and baseline visit.
* WOCBP, male patients and their partners must use two forms of contraception, one of which is an effective barrier method, when participating in sexual activity which could result in conception throughout the study and for 28 days following the last dose of study medication.
Exclusion Criteria:
* Infected with HIV-2
* Any medical, psychiatric or substance misuse disorders felt by the investigator to impact on the subject's ability to participate in the study, including a positive urine test for drugs of abuse (cannabinoids are not exclusionary).
* Disallowed concomitant medication as per the summary of product characteristics for darunavir or rilpivirine (see section 5.2).
* Any genotypic resistance mutations on screening or prior tests to darunavir (V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V) or rilpivirine (K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, H221Y, F227C, M230I, and M230L).
* Screening ALT or AST elevation greater than 5 times the upper limit of normal.
* Any active opportunistic infection within 4 weeks prior to planned baseline visit.
* Any active cardiovascular, pulmonary, hepatic, renal or metabolic disease, or therapy used to treat these diseases, which in the opinion of the investigator could affect the absorption, distribution, metabolism or efficacy of the study medication.
* Any known or suspected allergic reaction to the investigational products or excipients (including E110 allergy with regard to darunavir tablets).
* Hepatitis B or C co-infection (defined as positive hepatitis B surface antigen or positive hepatitis C antibody; patients with positive hepatitis C antibody with undetectable RNA will be eligible for inclusion).
* Estimated GFR (MDRD method) less than 50 ml/min
* Use of proton pump inhibitors, or H-2 antagonists more than once daily-Subject has one or more of the following risk factors for QTc prolongation:
i. a confirmed prolongation of QT/QTc interval, e.g., repeated demonstration of QTcF (Fridericia correction) interval \> 450 ms in the screening ECG. ii. pathological Q-waves (defined as Q-wave \> 40 ms or depth \> 0.4-0.5 mV). iii. evidence of ventricular pre-excitation. iv. electrocardiographic evidence of complete or incomplete left bundle branch block or complete or clinically significant incomplete right bundle branch block. v. evidence of second or third degree heart block. vi. intraventricular conduction delay with QRS duration \> 120 ms. vii. bradycardia as defined by sinus rate \< 50 bpm. viii. personal or family history of long QT syndrome. ix. personal history of cardiac disease (including congenital heart disease), symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia. x. syncopal episodes. xi. risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, hypomagnesemia).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01736761
Study Brief:
Protocol Section:
NCT01736761