Infection, Human Immunodeficiency Virus I, HIV Infection
Conditions
Keywords
HIV infected, therapy-naive subjects
Brief summary
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.
Detailed description
A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects
Interventions
Sponsors
ViiV Healthcare
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
* HIV infected, therapy-naive subjects. * Females must be of either non-childbearing age, or have a negative pregnancy test. * All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study. * Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3. * Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit. * Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI). * Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed. * Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions. * Signed and dated written informed consent prior to study entry.
Exclusion criteria
* No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening. * No active Class C AIDS-defining illness. * No laboratory abnormalities at screen. * No significant blood loss prior to study start. * No pregnant or breastfeeding women. * Additional qualifying criteria to be determined by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy. | — |
Countries
Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom, United States
Outcome results
None listed