A Phase 2b study to select a once daily oral dose of GSK2248761 in HIV-1 infected antiretroviral therapy experienced adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. - ND
- Conditions
- HIV-1 infected antiretroviral therapy experienced adult subjectsMedDRA version: 9.1Level: LLTClassification code 10008922
- Registration Number
- EUCTR2010-018532-40-IT
- Lead Sponsor
- ViiV Healthcare UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1) HIV-1 infected adults =18 years of age. A female is eligible to enter and participate in the study if she falls into one of the following categories: a. Non-childbearing potential; or, b. Child-bearing potential, with a negative pregnancy test at screen and Day 1 and agrees to one of the methods of contraception listed below. Premenarchal females who develop child-bearing potential while on study will also be expected to follow one of the methods of contraception listed below: - Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications. Should a subject of child-bearing potential decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the other contraception methods listed below: - Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide). - Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion). - Any other method with published data showing that the lowest expected failure rate for that method is <1% per year. Note: Since no data is currently available on interactions between hormonal contraceptives and GSK2248761, hormonal contraceptives are excluded medications in this study unless supportive drug interaction data becomes available. Note:Non-child-bearing potential is defined as pre-menopausal with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or post-menopausal defined as 24 months of spontaneous amenorrhea. Any contraception method must be used consistently and in accordance with the approved product label. All study subjects should be counseled on the practice of safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide). 2) HIV-1 infection with a screening plasma HIV-1 RNA =400copies/mL; 3) Previously received or current treatment with antiretroviral therapy (HAART) for HIV-1 infection (patient may be off ART at time of screening); 4) HIV-1 harboring NNRTI resistance by screening genotype (defined as the presence of =1 NNRTI resistance-associated mutations.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusionary Medical Conditions: 1. Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the subject’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject; 2. Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to take oral medication; 3. Women who are currently breastfeeding; 4. Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy; 5. History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic hepatitis B virus (HBV) infection (HBsAg positive). Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; subjects who are anticipated to require such therapy during the randomized portion of the study must be excluded; 6. History of liver cirrhosis with or without hepatitis viral co-infection; 7. Ongoing or clinically relevant pancreatitis; 8. History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia; 9. Personal or known family history of prolonged QT syndrome; 10. History or presence of allergy or intolerance to the study drugs or their components, or a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method