A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects.
- Conditions
- HIV-1 infected antiretroviral (ART) - naïve adult subjectsMedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2009-017950-11-GB
- Lead Sponsor
- ViiV Healthcare UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 822
Eligible subjects must
•be able to understand and comply with protocol requirements, instructions, and restrictions.
•be likely to complete the study as planned.
•be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease).
Laboratory results from the central laboratory services provided by this trial will be used to assess eligibility. If results from the central laboratory (e.g., genotype results) will delay screening beyond the defined 28-day period, use of local laboratory results may be used only after consultation and agreement with GSK.
Subjects eligible for enrolment in this study must meet all of the following criteria:
1.HIV-1 infected adults > 18 years of age.
2.A female may be eligible to enter and participate in the study if she:
a)is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and >45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
b)is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
•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.
•Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide).
•Approved hormonal contraception (see the SPM for a listing of examples of 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, see the SPM for a listing of example approved IUDs).
•Any other method with published data showing that the expected failure rate is <1% per year.
Any contraception method must be used consistently and in accordance with the approved product label.
All subjects participating in the study should be counselled on safer sexual practices including the use of effective barrier methods (e.g., male condom/spermicide).
3.HIV-1 infection as documented by Screening plasma HIV-1 RNA >1000 c/mL;
4.Antiretroviral-naïve (< 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
5.Signed and dated written informed consent is obtained from the subject or the subject’s legal representative prior to screening.
6.For subjects enrolled 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.
Note: subjects starting abacavir as part of the NRTI backbone must be or have been screened and be negative for the HLA-B*5701 allele.
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 Num
Subjects meeting any of the following criteria must not be enrolled in the study:
Exclusionary medical conditions
1.Women who are breastfeeding;
2.Any evidence of an active Center for Disease and Prevention Control (CDC) Category C disease [CDC, 1992], except cutaneous Kaposi’s sarcoma not requiring systemic therapy or historic or current CD4+ cell levels <200cells/mm3;
3.Subjects with moderate to severe hepatic impairment as determined by Child-Pugh classification (see Appendix 1);
4.Anticipated need for HCV therapy during the study;
5.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class;
6.History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and GSK medical monitor for inclusion of the subject;
Exclusionary Treatments prior to Screening or Day 1
7.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening;
8.Treatment with any of the following agents within 28 days of Screening;
• radiation therapy;
• cytotoxic chemotherapeutic agents;
• any immunomodulator;
9.Treatment with any agent, except recognized ART as allowed above (Section 4.2), with documented activity against HIV-1 in vitro within 28 days of first dose of IP;
10.Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP;
11.French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational agent 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;
Exclusionary Lab Values or Clinical Assessments at Screening
12.Any evidence of primary viral resistance in the Screening result or, if known, any historical resistance test result. Note: retests of Screening genotypes are not allowed;
13.Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period to verify a result). Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study of an investigational compound is exclusionary;
14.Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN);
15.ALT > 3xULN and bilirubin > 1.5xULN (with >35% direct bilirubin);
16.Subject has estimated creatinine clearance <50 mL/min via Cockroft-Gault method;
17.Recent history (<3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
Notwithstanding these minimum inclusion and exclusion criteria, Investigators must also follow country specific guidelines where the
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