A phase 3 clinical trial to compare the safety and effectiveness of GSK1349572 and abacavir/lamivudine compared to Atripla over 96 weeks in patients with HIV infection who have not previously received treatment.
- Conditions
- HIV-1 infected antiretroviral therapy naive adult subjects.MedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-020983-39-GB
- Lead Sponsor
- ViiV Healthcare UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 844
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).
• 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 an example listing of approved IUDs).
• Any other method with published data showing that the expected failure rate is <1% per year.
• Hormonal contraception plus a barrier method. Hormonal contraception alone will not be considered adequate for inclusion into or participation in this study (due to potential receipt of blinded efavirenz in this trial).
3. HIV-1 infection as documented by Screening plasma HIV-1 RNA ?1000 c/mL;
4. Antiretroviral-naive (? 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
5. A negative HLA-B*5701 allele screening assessment.
6. Signed and dated written informed consent is obtained from the subject or the subject’s legal representative prior to screening.
7. 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.
8. Subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned.
9. Subject must be considered appropriate candidates for participation in an investigative clinical trial with oral medication e.g. no active substance abuse, acute major organ disease.
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 826
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
1. Women who are breastfeeding.
2. Any evidence of an active Center for Disease Control and Prevention (CDC) Category C disease [CDC, 1992], except cutaneous Kaposi’s sarcoma not requiring systemic therapy. Subjects may be enrolled provided they are on stable, anti-infective treatment or profhylaxis regimen and are clinically improving on baseline visit (Historical or current CD4 cell counts less than 200cells/mm3 are not exclusionary).
3. Subjects with any degree of hepatic impairment.
4. Positive for Hepatitis B at screening (+HbsAg), or anticipated need for HCV therapy during the study.
5. Recent history (=3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
6. History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
7. 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 Study medical monitor for inclusion of the subject.
Exclusionary Treatments prior to Screening or Day 1
8. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening;
9. Treatment with any of the following agents within 28 days of Screening
i. radiation therapy
ii. cytotoxic chemotherapeutic agents
iii. any immunomodulator
10. Treatment with any agent, except recognized ART as allowed within inclusion criteria, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP). Allowed ART cannot be given within 28 days of first dose.
11. 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.
12. 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 if the subject will participate simultaneously in another clinical study.
Exclusionary Laboratory or Clinical Assessments at Screening
13. 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.
14. Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period); 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.
15. Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).
16.ALT =3xULN and bilirubin =1.5xULN (with >35% direct bilirubin).
17.Subject has creatinine clearance of <50mL/min via Coc
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