Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects - CNA109586

Conditions: Antiretroviral-Naive, HIV-1 Infected Adults
MedDRA version: 9.1Level: LLTClassification code 10008922Term: Chronic infection with HIV

Registration Number: EUCTR2007-000454-31-BE

Lead Sponsor: GlaxoSmithKline Research and Development Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

Inclusion Criteria

1.Subject is >or equal to 18 years of age.
2.Subject is antiretroviral-naïve (defined as having no previous therapy with any NNRTI and < or equal to 14 days of prior therapy with any other antiretroviral).
3.Subject has plasma HIV-1 RNA >or equal to1,000 copies/mL at screening. This test may be repeated once within the 45-day screening window.
4.Subject is willing and able to understand and provide written informed consent prior to participation in this study.
5.A female is eligible to enter and participate in the study if she is of:
a.Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
b.Child-bearing potential, has a negative pregnancy test at screen and agrees to one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician):
•Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, 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). Hormonal contraception will not be considered adequate for inclusion into this study
•Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year.
•Sterilization (female subject or male partner of female subject).
All subjects participating in the study should be counselled on the practice of safer sex.
6.Prior to randomization, subjects must have been screened and be negative for the HLA-B*5701 allele. Test may be performed by local laboratory and results must be available for source document verification according to local practices.

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

Exclusion Criteria

1.Subject is in the initial acute phase of a CDC Clinical Category C infection at Baseline. Subjects may be enrolled provided they are receiving treatment for such infections and are clinically improving at the Baseline visit.
2.Subject is enrolled in one or more investigational drug protocols, which may impact HIV RNA suppression.
3.Subject is, in the opinion of the Investigator, unable to complete the study dosing period and protocol evaluations and assessments.
4.Subject is either pregnant or breastfeeding.
5.Subject suffers from a serious medical condition, which in the opinion of the Investigator would compromise the safety of the subject.
6.Subject has a pre-existing mental, physical, or substance abuse disorder which, in the opinion of the Investigator, may interfere with the subject’s ability to comply with the dosing schedule and protocol evaluations and assessments.
7.Subject has a history of inflammatory bowel disease or intestinal malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which, in the opinion of Investigator, may interfere with drug absorption or render the subject unable to take oral medication.
8.Subject has any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the 45-day screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.
9.Subject has an estimated creatinine clearance within the screening period <50mL/min via the Cockcroft-Gault method as determined and calculated by the central laboratory. Re-testing will not be permitted.
10.Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).
11.Subjects with a history of thyroid disease, hyperparathyroid disease, chronic hyper or hypocalcemia, vitamin D deficiency, or receiving thyroid hormone or parathyroid hormone replacement within 28 days prior to screening are excluded.
12.Subjects with a history of rheumatoid arthritis or other systemic inflammatory arthritis are excluded.
13.Subjects who are hepatitis B virus surface antigen (HBVsAg) positive at screening are excluded.
14.Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents within the study period.
15.Subject has received treatment with an HIV-1 immunotherapeutic vaccine or any agents with documented activity against HIV-1 in vitro within 28 days prior to Screening, or an anticipated need during the study.
16.Subjects who require treatment with any of a protocol specified list of medications within 28 days of commencement of investigational product, or an anticipated need during the study.
17.Subject has a history of allergy to any of the protocol-specified medications or any excipients therein.
18.Subject has evidence of genotypic resistance at screening (according to central lab interpretation) or prior documented evidence of genotypic and/or phenotypic (above threshold for reduced susceptibility) resistance to any of the following drugs: efavirenz, abacavir, lamivudine, tenofovir, emtricitabine.
19.Subjects who are unsuitable for DEXA scanning should be excluded, including 1) Less than three vertebra in the range of L1 to L4 that are suitable for BMD m

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