GW873140 In Combination With Kaletra In HIV Infected Subjects

Stopped early · Phase 2

Conditions studied: Infection, Human Immunodeficiency Virus I, HIV Infection

In brief

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.

Key facts

Study ID

NCT00102778

Run by

ViiV Healthcare

People needed

175

Starts

2004-12-01

Expected to finish

2007-09-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Bradenton, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Jackson, Mississippi, United States
• GSK Investigational Site — Santa Fe, New Mexico, United States
• GSK Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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