Status:
TERMINATED
GW873140 In Combination With Kaletra In HIV Infected Subjects
Lead Sponsor:
ViiV Healthcare
Conditions:
Infection, Human Immunodeficiency Virus I
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00102778
Start Date
December 1 2004
End Date
September 1 2007
Last Update
May 30 2017
Active Locations (70)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85006
2
GSK Investigational Site
Tucson, Arizona, United States, 85745
3
GSK Investigational Site
Fountain Valley, California, United States, 92708
4
GSK Investigational Site
Long Beach, California, United States, 90813