HIV Infection
Conditions
Keywords
1592U89, GR109714, abacavir, lamivudine, fixed-dose combination, once-daily, twice-daily, HIV infection, naive
Brief summary
This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.
Detailed description
A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.
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
No
Inclusion criteria
* Have HIV-1 infection. * Had not received any prior HIV treatment for more than 14 days. * At least 1000 copies of HIV-1 RNA. * Willing to provide signed informed consent.
Exclusion criteria
* Enrolled in other investigational drug studies. * Female subjects who are pregnant or breastfeeding. * History of allergy or hypersensitivity to abacavir or lamivudine. * Certain medical conditions that would make subjects ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of treatment-limiting adverse events after starting study drugs. | — |
Secondary
| Measure | Time frame |
|---|---|
| completion of educational training | — |
| subject satisfaction with treatment | — |
| occurrence of abacavir HSR | — |
| change in HIV-1 RNA from BL | — |
| change in CD4 measure from BL. | — |
| adherence to study medications | — |
Countries
United States
Outcome results
None listed