GW873140 In Combination With Kaletra In HIV Infected Subjects

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects

Conditions
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HIV Infection, Infection, Human Immunodeficiency Virus I

Intervention / Treatment
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* Drug: GW873140
* Drug: Kaletra (lopinavir/ritonavir)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW873140|nan|
|Drug: Kaletra (lopinavir/ritonavir)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infected, therapy-naive subjects