HIV-1 infection in ART-naïve subjects. MedDRA version: 14.0 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: dolutegravir
Product Code: GSK1349572
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dolutegravir
CAS Number: 1051375-19-9
Current Sponsor code: GSK1349572
Concentration un
Sponsors
Viiv Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 central laboratory services (e.g., genotypes results) will delay screening beyond the defined 28 day period, use of local laboratory services may be used only after consultation and agreement with the study medical monitor. Subjects eligible for enrollment in this study must meet all of the following: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: Exclusionary medical conditions 1.Women who are pregnant or 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 or historic or current CD4+ cell levels 5 times the upper limit of normal (ULN); 15.ALT ? 3xULN and bilirubin ? 1.5xULN (with 35% direct bilirubin); 16.Subject has creatinine clearance of <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 they exist when making decisions about subjects who are eligible for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferior antiviral activity of DTG 50 mg administered once daily compared to DRV/r 800 mg/100 mg once daily over 48 weeks in HIV-1 infected therapy-naïve subjects.;Secondary Objective: ?To demonstrate the antiviral activity of DTG compared to DRV/r over 96 weeks; ?To compare the effects of DTG and DRV/r on fasting glucose and lipids over time; ?To compare the change in symptom distress score for subjects treated with DTG and DRV/r over time; ?To compare the change in utility score, treatment satisfaction, and health related quality of life for subjects treated with DTG and DRV/r over time. ?To compare the tolerability, long-term safety, incidence of HIV-associated conditions, antiviral and immunologic activity of DTG to DRV/r over time; ?To assess the development of viral resistance in subjects experiencing virologic failure; ?To evaluate the effect of patient characteristics (i.e., demographic factors, HIV-1 subtype) on response to DTG and DRV/r over time.;Primary end point(s): The primary endpoint for this study will be the proportion of subjects with HIV-1 RNA <50 c/mL through Week 48 using the snapshot (MSDF) algorithm (see Section 8.3.2).;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints ?Time to viral suppression (<50 copies/mL) through Week 48; ?Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 96; ?Proportion of subjects with plasma HIV-1 RNA <400 c/mL at Weeks 48 and 96; ?Absolute values and change from baseline in plasma HIV-1 RNA over time; ?Absolute values and changes from baseline in CD4+ and CD8+ T cell counts over time; ?Incidence of disease progression (HIV-associated conditions, AIDS and death).;Timepoint(s) of evaluation of this end point: Overtime through Weeks 48 and 96 | — |
Countries
France, Germany, Italy, Romania, Russian Federation, Spain, Switzerland, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research and Development Ltd
Outcome results
None listed