Treatment of HIV-1 infection. MedDRA version: 9.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV
Conditions
Interventions
Trade Name: Telzir
Product Name: Telzir
Product Code: GW433908
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: fosamprenavir calcium
Current Sponsor code: GW433908
Concentration unit: mg
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is =18 years of age 2. Subject is antiretroviral-naïve (defined as having =14 days of prior therapy with any antiretroviral agent). 3. Subject has plasma HIV-1 RNA =1,000 copies/mL at screening. 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 (serum ß-HCG) 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 permitted in this study - Any intrauterine device (IUD) with published data showing that the expected failure rate is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 either pregnant or breastfeeding. 4. Subject has an estimated creatinine clearance 5 times the upper limit of normal (ULN) or hepatic impairment as determined by Child-Pugh Score = 5. 6. Subject is receiving, or has received within 90 days prior to screen, any lipid lowering agent, including drugs from the following classes: HMG-CoA reductase inhibitors (statins), niacin, fibrates, bile acid sequestrants, and/or fish oil supplements. Subjects anticipated to require initiation of therapy with these agents within 12 weeks of Baseline are not eligible to participate. 7. Subject has evidence of genotypic (as defined by the current ANRS AC-11 algorithm) resistance at screening or prior documented evidence of genotypic and/or phenotypic (above threshold for reduced susceptibility) resistance to amprenavir/ritonavir, abacavir or lamivudine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferior antiviral response of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg BID, both administered with ABC/3TC FDC QD.;Secondary Objective: •To demonstrate a superior fasting non-HDL lipid profile in subjects receiving fosamprenavir/ritonavir (FPV/rtv) 1400mg/100mg QD compared to FPV/rtv 700mg/100mg BID, both administered with ABC/3TC FDC QD. • To compare fasting lipid profiles in subjects receiving FPV/rtv 1400mg/100mg QD compared to FPV/rtv 700mg/100mg BID, both administered with ABC/3TC FDC QD. • To compare virologic and immunologic responses in subjects receiving FPV/rtv 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg BID, both administered with ABC/3TC FDC QD. • To compare safety and tolerability in subjects receiving FPV/rtv 1400mg/100mg QD compared to FPV/rtv 700mg/100mg BID, both administered with ABC/3TC FDC QD. • To evaluate viral genotypic and phenotypic resistance patterns in subjects experiencing virologic failure • To characterize steady-state plasma amprenavir and ritonavir trough concentrations in subjects receiving FPV/rtv 1400mg/100mg QD or FPV/rtv 700/100mg BID;Primary end point(s): Proportion of subjects with HIV-1 RNA <400c/mL over 48 weeks by ITT-E, TLOVR analysis | — |
Countries
Belgium, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed