HIV Infection, Infection, Human Immunodeficiency Virus
Conditions
Keywords
ritonavir, abacavir, HIV, lopinavir, lamivudine, fosamprenavir, Epzicom
Brief summary
This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.
Detailed description
A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* HIV infected subjects that are naive to anti-HIV therapy. * History of a positive HIV test. * At least 1000 copies/mL of HIV in their blood as screening.
Exclusion criteria
* Active HIV-related diseases. * Taking other investigational drugs. * Pregnant or breastfeeding females. * Not be suitable to participate per investigator opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events. | — |
Countries
Austria, Belgium, Canada, France, Germany, Italy, Latvia, Luxembourg, Poland, Portugal, Romania, Spain, Switzerland, United States
Outcome results
None listed