Treatment of HIV-1 infections
Conditions
Interventions
Product Name: GW873140
Product Code: GW873140
Pharmaceutical Form: Coated tablet
CAS Number: 461023-63-2
Concentration unit: mg milligram(s)
Concentration number: 200-
Pharmaceutical form of the place
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.HIV-1 infected subjects aged 13 years or older (or = 18 where required by local regulatory agencies). Females must fall into one of the following categories: •Non-childbearing potential defined as women who are surgically sterile or post-menopausal. •Childbearing potential: has a negative pregnancy test within 28 days prior to administration of investigational products and agrees to use a proven double barrier method of contraception. 2.Screening plasma HIV-1 RNA = 10,000 copies/mL. 3.CD4 cell count > 100 cells/mm3 at screening. 4.R5-tropic virus at screening. 5.No drug resistance mutations in HIV-1 RT based on pol genotype determined at screening. 6.ART-naïve, defined as = 2 weeks of treatment with either a PI or an NRTI/NtRTI, or =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Detection of any X4-tropic virus, at screening. 2.Detection of any resistance-conferring mutation in HIV-1 RT based on genotypic testing at screening. 3Subject with active Class C AIDS-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition. Subjects with an historic or current CD4+ cell count nadir <200 cells/mm3 will not be excluded on that criterion. Subjects with a history of a CDC class C event will be permitted to enroll 4.Any acute laboratory abnormality at screen 5.Significant blood loss within 56 days prior to screening. 6.Pregnant or lacatating women 7.Any clinically significant finding on screening or baseline ECG. 8.History of clinically relevant pancreatitis or hepatitis within the previous 6 months [asymptomatic individuals with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection will not be excluded 9.Any condition may interfere with subject’s ability to comply with the dosing schedule and protocol evaluations or compromise safety of subject. 10.Any condition which might interfere with ADME of drug 11.History of a drug or other allergy or known hypersensitivity to any study medication or excipients. 12.Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of administration. 13.Treatment with immunomodulating agents or any agent with known anti-HIV activity within 90 days of administration. 14.Any immunisation within 30 days prior to first dose. 15.Prior investigational drug and/or vaccine trial(s) within 30 days or 5 half-lives, or twice the duration of the biological effect(whichever is longer), prior screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To select a GW873140 dose for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with COM(ZDV/3TC) in HIV-1 infected therapy-naive subjects.;Secondary Objective: • Long-term safety and antiviral activity of GW873140 in combination with COMBIVIR in HIV-1 infected therapy-naïve subjects. •Longitudinal effects of a GW873140-containing or control regimen on plasma viral tropism. • Development of viral resistance to GW873140 and other on-study drugs. • PK parameters of GW873140 in HIV-1 infected subjects receiving combination therapy. •Potential for PK interaction between GW873140 and ZDV or 3TC. •Exposure-response relationships and to explore the effect of various demographic factors on PK parameters. • Effect of different doses of GW873140 plus COMBIVIR on selected virological and immunological markers of HIV infection relative to a standard of care regimen. •Explore how bothersome certain symptoms are for subjects taking COMBIVIR + GW873140 or efavirenz, and how symptoms impact on health related quality of life. ;Primary end point(s): Proportion of subjects with plasma HIV-1 RNA <400 copies/mL remaining on the randomised treatment regimen through Week 12 | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed