A GSK1349572 Open Label Protocol for HIV infected, Adult Patients with Integrase Resistance - Expanded Access Programme

• Conditions: Treatment of Human Immunodeficiency Virus (HIV)-1 infection in patients with raltegravir (RAL) or elvitegravir (ELV) resistance who have limited treatment options.; MedDRA version: 15.0Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-001646-16-IT
• Lead Sponsor: VIIV HEALTHCARE UK LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-21
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Male or female patients aged =18 years NOTE: all female patients of child-bearing potential should use every precaution to prevent pregnancy. Contraception guidelines include: • Complete abstinence from intercourse from 2 weeks prior to administration of DTG, throughout receipt of DTG, and for at least 2 weeks after discontinuation of DTG; • Double barrier method (male condom/spermicide, male condom/diaphragm,diaphragm/spermicide); • Approved hormonal contraception; • Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion); • Male partner sterilization prior to the female patient's entry into the study, and this male is the sole partner for that patient; • Any other method with published data showing that the expectedfailure rate is <1% per year. Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP. All patients participating in the study should be counseled on the practice of safer sexual practices including the use of effective barrier methods (e.g., male condom/spermicide). • Documented plasma HIV-1 RNA levels =400 copies/mL within 3 months prior to the Screening visit.Documented RAL or ELV resistance in the patient's medical records (evidence of phenotypic and/or genotypic resistance must be provided to qualify for the EAP program). If resistance is not documented, Investigators may, at their own expense, test potential recruits. • Inability to construct a viable background regimen of ART with commercially available medications. • The patient/legal guardian or representative has given written informed consent to treatment prior to any program-specific assessments are initiated in accordance with country-specific regulatory authority requirements.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 990
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Deviations from exclusion criteria are not allowed because they can potentially jeopardize patient safety. Therefore, adherence to the criteria as specified in the protocol is essential. Patients meeting any of the following criteria must not be enrolled in the program: 1. Patient has estimated creatinine clearance (CrCl) <30 mL/min via Cockcroft-Gault method [Cockcroft, 1976]. Calculated CrCl (mL/min) = (140 - age [years]) x weight (kg)/ [72 × serum creatinine (mg/100mL)] Female patients: multiply by 0.85 In order to use SI units, the following formula may be used: Calculated CrCl (mL/min) = (140 - age [years]) x weight (kg) x 1.23/serum creatinine (µmol/L) Female patients: multiply by 0.85 2. Females who are pregnant or breastfeeding. 3. Patients who have had a known or suspected allergic reaction to an INI. 4. Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) within 1 month of treatment initiation and/or at last ALT determination. 5. ALT >3 times ULN and total bilirubin >1.5 times ULN (with >35% direct bilirubin within 1 month of treatment initiation) and/or at last ALT and bilirubin determinations. 6. Evidence for severe hepatic impairment (Child-Pugh class C). 7. Patients who are eligible for, and have access to, an actively enrolling DTG Phase III clinical trial. 8. Any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during Screening of medical history or physical examination, which, in the opinion of the Investigator would interfere with patient safety or compliance. 9. Patient requires or is anticipated to require any of the prohibited concomitant therapy as listed in Section 5.6.2. NOTE: Patients should not be considered for the EAP if they are eligible
and able to participate in any of the clinical treatment trials of DTG in
treatment-experienced patients (protocols ING111762, ING112961 or
ING112574). Please refer to any national or local requirements for
participation in EAPs. In that instance (assuming
consent is obtained), the patient should preferentially be enrolled into
the ongoing clinical trial to allow detailed data collection. Patients
should not be treated in this EAP if they have previously been treated
with DTG in another clinical trial.
Notwithstanding these minimum inclusion and exclusion criteria,
Investigators must also follow country specific guidelines where they
exist when making decisions about patients who are eligible for study
participation.

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 is to provide access in an open-label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable antiretroviral (ARV) regimen for therapy. Eligible patients are those who are unable to participate in the Phase III DTG studies.;Secondary Objective: The secondary objective is to assess any serious adverse events (SAEs) and any adverse events (AEs) that lead to the discontinuation of DTG 50 mg twice daily (BID).;Primary end point(s): This is an open-label, expanded access study. No formal hypotheses testing will be performed. Data will provide only descriptive information on safety.;Timepoint(s) of evaluation of this end point: not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable