A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects.
- Conditions
- HIV-1 infected antiretroviral therapy naïve adult subjectsMedDRA version: 9.1Level: LLTClassification code 10008922Term: Chronic infection with HIV
- Registration Number
- EUCTR2009-010269-21-DE
- Lead Sponsor
- ViiV Healthcare UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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 defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy or post-menopausal defined as 24 months of spontaneous amenorrhea; or,
b. Child-bearing potential, with a negative pregnancy test at screen and a negative pregnancy test at Day1, who agrees to use one of the methods of contraception listed in the protocol. Premenarchal females who develop child-bearing potential while on study will also be expected to follow one to the methods of contraception listed in the protocol.
2.HIV-1 infection with a screening plasma HIV-1 RNA =1000 c/mL
3.CD4+ cell count =200 cells/mm3 (or higher as local guidelines dictate)
4.ART-naive defined as having <10 days of prior therapy with any antiretroviral agent. Any previous exposure to an HIV integrase inhibitor other than GSK1349572 will be exclusionary.
5.Subject has no evidence of viral resistance to any antiretroviral drug indicative of primary transmitted resistance in screening genotype or historical resistance test result
6.Able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned
7.Signed and dated written informed consent is obtained from the subject or the subject’s legal representative prior to screening.
8. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
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
1.Any pre-existing mental, physical, or substance abuse disorder which 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.Women who are pregnant or breastfeeding
3.Any evidence of an active CDC Category C disease except cutaneous Kaposi’s sarcoma not requiring systemic therapy at the screening visit.
4.Previous participation in an experimental drug and/or vaccine trials (s) within 30 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer
5.History of ongoing or clinically relevant pancreatitis or hepatitis within the previous 6 months, including chronic HBV infection.
6.Serious medical condition which would compromise the safety of the subject
7.Any condition which may interfere with the ADME of the drug or render the subject unable to take oral medication.
8.Any acute laboratory abnormality at screening, which would preclude the subject’s participation in the study of an investigational compound.
9. History of upper gastrointestinal bleed (unless in the opinion of the Investigator and Sponsor the primary cause was reversible and has been adequately treated) and/or subjects with active peptic ulcer disease
10.Subject has estimated creatinine clearance <50 mL/min
11.ALT =5 times ULN. Subjects with ALT > 2xULN but <5xULN may participate in the study if the abnormality will not interfere with the study procedures or compromise subject safety
12.Screening ALT =3xULN and bilirubin =1.5xULN
13. Lipase >3xULN
14. Hemoglobin <100 g/L(10g/dL)
15.History or presence of allergy or intolerance to the study drugs or drugs of their class, or a history of drug or other allergy that contraindicates participation.
16.Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need during the study
17.Required treatment with immunomodulators within 28 days or subject has received an HIV-1 immunotherapeutic vaccine within 90 days
18.Treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study administration
19.History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia
20.Personal or family history of prolonged QT syndrome
21.Any clinically significant finding on screening or baseline ECG
22.Significant blood loss within a 56 day period
23.Immunization within 30 days
24. French subjects: The subject has participated in any study using an investigational drug during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine – whichever is longer, prior to screening for the study or the subject will participate simultaneously in another clinical study.
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