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GW873140 In Combination With Kaletra In HIV Infected Subjects

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102778
First Posted: February 2, 2005
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ViiV Healthcare
February 1, 2005
February 2, 2005
May 30, 2017
December 2004
September 2007   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00102778 on ClinicalTrials.gov Archive Site
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.
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GW873140 In Combination With Kaletra In HIV Infected Subjects
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
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.
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Infection, Human Immunodeficiency Virus I
  • HIV Infection
  • Drug: GW873140
  • Drug: Kaletra (lopinavir/ritonavir)
    Other Name: GW873140
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
175
September 2007
September 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Portugal,   Spain,   United Kingdom,   United States
 
 
NCT00102778
100136
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ViiV Healthcare
ViiV Healthcare
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
ViiV Healthcare
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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